A Phase 1 interventional study of Acetaminophen 650mg+Dextromethorphan 20mg+Phenylephrine 10mg and Acetaminophen 325mg+Dextromethorphan 10mg+Phenylephrine 5mg in Common Cold, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to male participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-24.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
This clinical study will be conducted to characterize the gastrointestinal transit of two multi-symptoms formulations by inclusion of a radiolabel marker.
This study will be an open label, randomized, single dose, parallel groups gamma scintigraphic study. A total of 28 healthy male participants will be randomized (14 participantper treatment arm) in order to have 24 evaluable participants (12 participants per treatment arm). Participants will be randomized to receive either a single dose Treatment A (Theraflu daytime Severe Cold \& Cough powder) or single dose of Treatment B (Theraflu ExpressMax Daytime Severe Cold and Cough caplets). This study will consist of screening visit (Visit 1), followed by a treatment visit (Visit 2). Visit 2 includes two days: Day -1 and Day 1. On visit 2 (day -1) of the study, the study participants will be admitted to the unit at approximately 7 pm on the evening before study drug administration and will receive a standardized meal. Participants will be required to fast (nothing to eat or drink except non-carbonated water) from 10 hours prior until 4 hours after study drug administration. Water will be permitted until 1 hour prior to investigational product administration, and no additional fluids until the lunch meal will be served at approximately 4 hours post dose. Participants will then be given a standard lunch at 4 hours post-dose, a standard dinner at 10 hours post-dose on Day 1. Participants will be discharged from the unit after the last scintigraphic imaging is performed, blood sample for laboratory test will be taken as well as a brief physical examination. Scintigraphic acquisitions will be taken beginning after dose administration until 10 hours post-dose.
219 studies on the registry are indexed under Common Cold; 23 are open to participants now.
This study's enrollment of 28 is below the median of 150 across 184 interventional studies indexed under Common Cold.
Browse Common Cold studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single dose (1 sachet) of the investigational product (Acetaminophen 650mg+Dextromethorphan 20mg+Phenylephrine 10mg).
Drug: Acetaminophen 650mg+Dextromethorphan 20mg+Phenylephrine 10mg
Participants will receive a single dose (2 caplets) of the investigational product (Acetaminophen 325mg+Dextromethorphan 10mg+Phenylephrine 5mg).
Drug: Acetaminophen 325mg+Dextromethorphan 10mg+Phenylephrine 5mg
Drug page: Acetaminophen
Contents of the sachet will be emptied into a glass bottle and 225 mL of hot, but not boiling water (approximately 90-95°C), will be added to the container and mixed to dissolve the contents of the sachet. The dissolved solution will be allowed to cool to approximately 40 - 50 degree Celsius (°C). After cooling, a small volume (1 to 10 microliters \[mcL\]) of 99mTc-DTPA (Technetium-99m-diethylene-triamine-pentaacetate will be added to the drug solution in to achieve a maximum of 108 curie(mcCi) i.e.4 megabecquerel \[MBq\] per individual dose at the time of dosing. The container will be capped and maintained at a temperature between 35-45°C at time of dosing and then participants will be instructed to consume the hot drink entirely within 30 seconds.
Also known as: Theraflu daytime severe cold and cough powder
Drug page: Acetaminophen
Caplet doses will be prepared by drilling hole of approximately(app.)1millimetre(mm)diameter and app.2-2.5mm deep into individual caplets.99mTc-DTPA(dissolved in normal saline)will be added into hole of each caplet as low volume liquid(0.5-2.0mcL)to achieve maximum of 54 mcCi(2MBq)per caplet at time of dosing(2caplets=108 mcCi\[4MBq\]dose per assessment visit).Applied liquid will be allowed to air dry,hole to be filled with equivalent powder blend from crushed caplet so drug content will remain constant for all caplets.Caplet will be sealed with appropriate material.Radiolabeled caplets will be packaged as unit doses(2 caplets per container)and maintained at room temperature until administration.Caplets will be swallowed with 225mL of noncarbonated room temperature water within 30 seconds.
Also known as: Theraflu expressmax daytime severe cold and cough caplets
Mean Time to Onset of Gastric Emptying
Mean time to onset of gastric emptying in participants who did not vomit shortly (within 60 minutes) after study drug administration was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 microcurie \[mcCi\] isotope-technetium-99m-diethylene-triamine-pentaacetate \[DTPA\]). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. Regions of interest (ROI) included the stomach, proximal small intestine, distal small intestine and colon.
Time frame: Predose until 10 hours post dose on Day 1
Mean Time to Complete Gastric Emptying
Mean time to complete gastric emptying in participants who did not vomit shortly (within 60 minutes) after study drug administration was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m-DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.
Time frame: Predose until 10 hours post dose on Day 1
Mean Time for Gastric Emptying by Measuring 25 Percent Values
Mean time to gastric emptying by 25 percent (GE25%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.
Time frame: Predose until 10 hours post dose on Day 1
Mean Time for Gastric Emptying by Measuring 50 Percent Values
Mean time to gastric emptying by 50 percent (GE50%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.
Time frame: Predose until 10 hours post dose on Day 1
Mean Time for Gastric Emptying by Measuring 90 Percent Values
Mean time to gastric emptying by 90 percent (GE90%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.
Time frame: Predose until 10 hours post dose on Day 1
Percentage of Radiolabeled Drug Remaining in the Stomach After 15 Minutes of Administration
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 15 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 15 minutes post dose on Day 1
Percentage of Radiolabeled Drug Remaining in the Stomach After 30 Minutes of Administration
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 30 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 30 minutes post dose on Day 1
Percentage of Radiolabeled Drug Remaining in the Stomach After 45 Minutes of Administration
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 45 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 45 minutes post dose on Day 1
Percentage of Radiolabeled Drug Remaining in the Stomach After 60 Minutes of Administration
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 60 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 60 minutes post dose on Day 1
Percentage of Radiolabeled Drug Remaining in the Stomach After 75 Minutes of Administration
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 75 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 75 minutes post dose on Day 1
Percentage of Radiolabeled Drug Remaining in the Stomach After 90 Minutes of Administration
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 90 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 90 minutes post dose on Day 1
Percentage of Radiolabeled Drug Remaining in the Stomach After 105 Minutes of Administration
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 105 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 105 minutes post dose on Day 1
Percentage of Radiolabeled Drug Remaining in the Stomach After 120 Minutes of Administration
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 120 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 120 minutes post dose on Day 1
Percentage of Radiolabeled Drug Remaining in the Stomach After 180 Minutes of Administration
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 180 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 180 minutes post dose on Day 1
Percentage of Radiolabeled Drug Remaining in the Stomach After 240 Minutes of Administration
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 240 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 240 minutes post dose on Day 1
Area Under the Gastric Emptying Curve From Time 0 to 15 Minutes
Area under the gastric emptying curve from time 0 to 15 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 15 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 15 minutes post dose on Day 1
Area Under the Gastric Emptying Curve From Time 0 to 30 Minutes
Area under the gastric emptying curve from time 0 to 30 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 30 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 30 minutes post dose on Day 1
Area Under the Gastric Emptying Curve From Time 0 to 45 Minutes
Area under the gastric emptying curve from time 0 to 45 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 45 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 45 minutes post dose on Day 1
Area Under the Gastric Emptying Curve From Time 0 to 60 Minutes
Area under the gastric emptying curve from time 0 to 60 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 60 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 60 minutes post dose on Day 1
Area Under the Gastric Emptying Curve From Time 0 to 75 Minutes
Area under the gastric emptying curve from time 0 to 75 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 75 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 75 minutes post dose on Day 1
Area Under the Gastric Emptying Curve From Time 0 to 90 Minutes
Area under the gastric emptying curve from time 0 to 90 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 90 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 90 minutes post dose on Day 1
Area Under the Gastric Emptying Curve From Time 0 to 105 Minutes
Area under the gastric emptying curve from time 0 to 105 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 105 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 105 minutes post dose on Day 1
Area Under the Gastric Emptying Curve From Time 0 to 120 Minutes
Area under the gastric emptying curve from time 0 to 120 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 120 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 120 minutes post dose on Day 1
Area Under the Gastric Emptying Curve From Time 0 to 180 Minutes
Area under the gastric emptying curve from time 0 to 180 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 180 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 180 minutes post dose on Day 1
Area Under the Gastric Emptying Curve From Time 0 to 240 Minutes
Area under the gastric emptying curve from time 0 to 240 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 240 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
Time frame: 240 minutes post dose on Day 1
Total Area Under the Gastric Emptying Curve
Total area under the gastric emptying curve was evaluated by scintigraphic imaging, performed after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation.
Time frame: Predose until 10 hours post dose on Day 1
Gastric Emptying Half-Life
Gastric emptying half-life was defined as the time required by the stomach to empty 50% of the ingested meal and was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation.
Time frame: Predose until 10 hours post dose on Day 1
Small Intestine Transit Time
Small intestinal transit time was calculated by determining the arrival time of the radiolabeled investigational drug formulation at the cecum or colon region from scintigraphic imaging and subtracting the gastric emptying value.
Time frame: Predose until 10 hours post dose on Day 1
Number of Participants With Clinically Significant Change in Laboratory Test Values
Haematological, biochemistry, urinalysis and virological parameters were analyzed. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter.
Time frame: From baseline up to Day 1
Participants were recruited from one center in USA.
| Milestone | Treatment Group A | Treatment Group B |
|---|---|---|
| Started | 14 | 14 |
| Completed | 14 | 14 |
| Not completed | 0 | 0 |
Mean time to onset of gastric emptying in participants who did not vomit shortly (within 60 minutes) after study drug administration was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 microcurie \[mcCi\] isotope-technetium-99m-diethylene-triamine-pentaacetate \[DTPA\]). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. Regions of interest (ROI) included the stomach, proximal small intestine, distal small intestine and colon.
| minutes | Treatment Group A | Treatment Group B |
|---|---|---|
| Mean Time to Onset of Gastric Emptying | 1.107 ± 1.2130 | 8.534 ± 6.6062 |
Mean time to complete gastric emptying in participants who did not vomit shortly (within 60 minutes) after study drug administration was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m-DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.
| minutes | Treatment Group A | Treatment Group B |
|---|---|---|
| Mean Time to Complete Gastric Emptying | 121.2 ± 47.76 | 65.3 ± 47.40 |
Mean time to gastric emptying by 25 percent (GE25%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.
| minutes | Treatment Group A | Treatment Group B |
|---|---|---|
| Mean Time for Gastric Emptying by Measuring 25 Percent Values | 12.614 ± 6.8249 | 12.171 ± 9.1819 |
Mean time to gastric emptying by 50 percent (GE50%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.
| minutes | Treatment Group A | Treatment Group B |
|---|---|---|
| Mean Time for Gastric Emptying by Measuring 50 Percent Values | 22.643 ± 11.4058 | 16.134 ± 11.8721 |
Mean time to gastric emptying by 90 percent (GE90%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.
| minutes | Treatment Group A | Treatment Group B |
|---|---|---|
| Mean Time for Gastric Emptying by Measuring 90 Percent Values | 84.929 ± 43.1606 | 36.214 ± 33.7711 |
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 15 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage of radiolabeled drug | Treatment Group A | Treatment Group B |
|---|---|---|
| Percentage of Radiolabeled Drug Remaining in the Stomach After 15 Minutes of Administration | 67.00 ± 13.260 | 49.77 ± 42.193 |
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 30 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage of radiolabeled drug | Treatment Group A | Treatment Group B |
|---|---|---|
| Percentage of Radiolabeled Drug Remaining in the Stomach After 30 Minutes of Administration | 33.24 ± 19.321 | 20.87 ± 26.697 |
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 45 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage of radiolabeled drug | Treatment Group A | Treatment Group B |
|---|---|---|
| Percentage of Radiolabeled Drug Remaining in the Stomach After 45 Minutes of Administration | 24.79 ± 16.334 | 7.21 ± 11.387 |
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 60 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage of radiolabeled drug | Treatment Group A | Treatment Group B |
|---|---|---|
| Percentage of Radiolabeled Drug Remaining in the Stomach After 60 Minutes of Administration | 20.07 ± 13.885 | 4.26 ± 10.378 |
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 75 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage of radiolabeled drug | Treatment Group A | Treatment Group B |
|---|---|---|
| Percentage of Radiolabeled Drug Remaining in the Stomach After 75 Minutes of Administration | 14.73 ± 13.350 | 3.28 ± 8.123 |
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 90 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage of radiolabeled drug | Treatment Group A | Treatment Group B |
|---|---|---|
| Percentage of Radiolabeled Drug Remaining in the Stomach After 90 Minutes of Administration | 8.84 ± 9.867 | 2.45 ± 6.164 |
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 105 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage of radiolabeled drug | Treatment Group A | Treatment Group B |
|---|---|---|
| Percentage of Radiolabeled Drug Remaining in the Stomach After 105 Minutes of Administration | 6.06 ± 8.145 | 1.72 ± 5.279 |
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 120 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage of radiolabeled drug | Treatment Group A | Treatment Group B |
|---|---|---|
| Percentage of Radiolabeled Drug Remaining in the Stomach After 120 Minutes of Administration | 4.34 ± 6.177 | 0.99 ± 3.546 |
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 180 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage of radiolabeled drug | Treatment Group A | Treatment Group B |
|---|---|---|
| Percentage of Radiolabeled Drug Remaining in the Stomach After 180 Minutes of Administration | 0.64 ± 2.108 | 0.00 ± 0.000 |
Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 240 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage of radiolabeled drug | Treatment Group A | Treatment Group B |
|---|---|---|
| Percentage of Radiolabeled Drug Remaining in the Stomach After 240 Minutes of Administration | 0.00 ± 0.00 | 0.00 ± 0.00 |
Area under the gastric emptying curve from time 0 to 15 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 15 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage dose*hour | Treatment Group A | Treatment Group B |
|---|---|---|
| Area Under the Gastric Emptying Curve From Time 0 to 15 Minutes | 19.38 ± 0.511 | 16.96 ± 1.769 |
Area under the gastric emptying curve from time 0 to 30 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 30 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage dose*hour | Treatment Group A | Treatment Group B |
|---|---|---|
| Area Under the Gastric Emptying Curve From Time 0 to 30 Minutes | 31.16 ± 1.598 | 25.11 ± 3.873 |
Area under the gastric emptying curve from time 0 to 45 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 45 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage dose*hour | Treatment Group A | Treatment Group B |
|---|---|---|
| Area Under the Gastric Emptying Curve From Time 0 to 45 Minutes | 38.36 ± 2.727 | 28.19 ± 4.864 |
Area under the gastric emptying curve from time 0 to 60 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 60 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage dose*hour | Treatment Group A | Treatment Group B |
|---|---|---|
| Area Under the Gastric Emptying Curve From Time 0 to 60 Minutes | 43.69 ± 3.620 | 29.60 ± 5.402 |
Area under the gastric emptying curve from time 0 to 75 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 75 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage dose*hour | Treatment Group A | Treatment Group B |
|---|---|---|
| Area Under the Gastric Emptying Curve From Time 0 to 75 Minutes | 48.71 ± 4.659 | 30.61 ± 5.888 |
Area under the gastric emptying curve from time 0 to 90 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 90 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage dose*hour | Treatment Group A | Treatment Group B |
|---|---|---|
| Area Under the Gastric Emptying Curve From Time 0 to 90 Minutes | 51.32 ± 5.242 | 31.29 ± 6.236 |
Area under the gastric emptying curve from time 0 to 105 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 105 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage dose*hour | Treatment Group A | Treatment Group B |
|---|---|---|
| Area Under the Gastric Emptying Curve From Time 0 to 105 Minutes | 53.16 ± 5.745 | 31.81 ± 6.529 |
Area under the gastric emptying curve from time 0 to 120 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 120 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage dose*hour | Treatment Group A | Treatment Group B |
|---|---|---|
| Area Under the Gastric Emptying Curve From Time 0 to 120 Minutes | 54.49 ± 6.138 | 32.15 ± 6.743 |
Area under the gastric emptying curve from time 0 to 180 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 180 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage dose*hour | Treatment Group A | Treatment Group B |
|---|---|---|
| Area Under the Gastric Emptying Curve From Time 0 to 180 Minutes | 56.69 ± 6.992 | 32.61 ± 7.069 |
Area under the gastric emptying curve from time 0 to 240 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 240 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.
| percentage dose*hour | Treatment Group A | Treatment Group B |
|---|---|---|
| Area Under the Gastric Emptying Curve From Time 0 to 240 Minutes | 56.80 ± 7.071 | 32.61 ± 7.069 |
Total area under the gastric emptying curve was evaluated by scintigraphic imaging, performed after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation.
| percentage dose*hour | Treatment Group A | Treatment Group B |
|---|---|---|
| Total Area Under the Gastric Emptying Curve | 56.80 ± 7.071 | 32.61 ± 7.069 |
Gastric emptying half-life was defined as the time required by the stomach to empty 50% of the ingested meal and was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation.
| minutes | Treatment Group A | Treatment Group B |
|---|---|---|
| Gastric Emptying Half-Life | 25.00 (6.8 to 52.0) | 5.00 (1.0 to 35.0) |
Small intestinal transit time was calculated by determining the arrival time of the radiolabeled investigational drug formulation at the cecum or colon region from scintigraphic imaging and subtracting the gastric emptying value.
| minutes | Treatment Group A | Treatment Group B |
|---|---|---|
| Small Intestine Transit Time | 184.0 (106 to 265) | 139.5 (61 to 243) |
Haematological, biochemistry, urinalysis and virological parameters were analyzed. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter.
| Participants | Treatment Group A | Treatment Group B |
|---|---|---|
| Number of Participants With Clinically Significant Change in Laboratory Test Values | 0 | 0 |
Collected over From signature of informed consent form up to 5 days after last administration of the investigational product (up to Day 6). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group A | 0/14 (0%) | 0/14 (0%) | 1/14 (7.1%) |
| Treatment Group B | 0/14 (0%) | 0/14 (0%) | 2/14 (14.3%) |
| Event | Treatment Group A | Treatment Group B |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 0/14 | 1/14 |
| NauseaGastrointestinal disorders | 0/14 | 1/14 |
| FatigueGeneral disorders | 1/14 | 0/14 |
| Alanine aminotransferase increasedInvestigations | 0/14 | 1/14 |
Safety population was defined as all participants who received a radiolabeled treatment A or B irrespective of whether the participant was included in the scintigraphy analysis.
| Age, Continuous(Years) | Treatment Group A | Treatment Group B | Total |
|---|---|---|---|
| Mean | 28.0 ± 8.74 | 28.8 ± 5.19 | 28.4 ± 7.06 |
| Sex: Female, Male(Participants) | Treatment Group A | Treatment Group B | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 14 | 14 | 28 |
| Race and Ethnicity Not Collected(Participants) | Treatment Group A | Treatment Group B | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Height(Centimeters) | Treatment Group A | Treatment Group B | Total |
|---|---|---|---|
| Mean | 183.1 ± 6.53 | 180.6 ± 7.00 | 181.9 ± 6.76 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Mar 2018, 0 months.
Results were first posted in Jun 2019, 1 year 2 months after primary completion.
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Studies of the drug tested here: Acetaminophen