A Phase 1 interventional study of Butamirate citrate and Sinecod in Healthy, sponsored by McNeil AB. Withdrawn at 1 site in Russian Federation. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-20.
Sponsored by McNeil AB (formerly part of Johnson & Johnson) · Phase 1, Interventional, and Basic science
The purpose of this study is to evaluate bioequivalence with respect to rate and extent of absorption of 2-phenylbuturic acid of the novel medication butamirate citrate syrup 1.5 milligrams per milliliter (mg/mL), and the medication sinecod syrup (vanilla) 1.5 mg/mL after single-dose administration in fasting condition by healthy volunteers.
McNeil AB is the lead sponsor of 42 studies on the registry; 1 is open to participants now.
First submitted before McNeil AB left Johnson & Johnson.
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.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
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 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.
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 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.
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.
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.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
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.
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.
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 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.
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.
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.
Participant will receive a single oral dose of butamirate citrate syrup 1.5 milligrams per milliliter (mg/mL) (Treatment A \[investigational product\]) on Day 1 in Treatment Period 1, followed by a single oral dose of sinecod syrup (vanilla) 1.5 mg/mL (Treatment B \[Reference product\]) on Day 11 in Treatment Period 2. A wash-out period of at least 10 days will be maintained between each treatment period.
Drug: Butamirate citrate · Drug: Sinecod
Participants will receive Treatment B on Day 1 in Treatment Period 1, followed by Treatment A on Day 11 in Treatment Period 2. A wash-out period of at least 10 days will be maintained between each treatment period.
Drug: Butamirate citrate · Drug: Sinecod
Butamirate citrate syrup will be administered orally.
Sinecod syrup will be administered orally.
Maximum Observed Plasma Concentration (Cmax) of 2-phenylbuturic Acid
Cmax is defined as the maximum observed plasma concentration of 2-phenylbuturic acid.
Time frame: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose
Area Under the Concentration Versus Time Curve from Start of Drug Administration Until the Time of the Last Measurable 2-phenylbuturic Acid Plasma Concentration (AUC [tau])
AUC (tau) is defined as the area under the concentration versus time curve from start of drug administration until the time of the last measurable 2-phenylbuturic acid plasma concentration.
Time frame: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose
Area Under the Concentration Versus Time Curve Extrapolated to Infinity (AUC [infinity]) of 2-phenylbuturic Acid
AUC (infinity) is defined as the area under the concentration versus time curve extrapolated to infinity of 2-phenylbuturic acid.
Time frame: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose on Days 1 and 11
Extrapolated part of Area Under the Concentration Versus Time Curve Extrapolated to Infinity (AUCextrap) of 2-phenylbuturic Acid
AUCextrap is defined as extrapolated part of AUC (infinity) of 2-phenylbuturic acid.
Time frame: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose on Days 1 and 11
Time at Which the Maximum Plasma Concentration of 2-phenylbuturic Acid is Observed (Tmax)
Tmax is defined as the time at which the maximum plasma concentration of 2-phenylbuturic acid is observed.
Time frame: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose on Days 1 and 11
Terminal Elimination Rate Constant (lambda[z]) for 2-phenylbuturic Acid in Plasma
Lambda(z) is defined as the rate at which the 2-phenylbuturic acid is removed from the body system.
Time frame: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose on Days 1 and 11
Terminal Elimination Half-life (t1/2) of 2-phenylbuturic Acid in Plasma
T1/2 is defined as the time it takes for the 2-phenylbuturic acid plasma concentration to reduce to half of its original value.
Time frame: Predose, 0.25, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72 hours postdose on Days 1 and 11
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
Time frame: Up to 29 days
Number of Participants with AEs by Severity
Number of participants with AEs by severity will be reported. The severity of AEs will be assessed by the medically qualified Investigator or designee using the following general categorical descriptors: a) Mild: awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with the volunteer's usual function or normal everyday activities; b) Moderate: sufficient discomfort is present to cause interference to some extent with the volunteer's usual function or normal everyday activity; c) Severe: extreme distress, causing significant impairment of functioning or incapacitation; interferes significantly with volunteer's usual function; prevents normal everyday activities.
Time frame: Up to 29 days
Number of Participants with AE Relationship to Investigational Product Assessment
Number of participants with AE relationship to investigational product assessment will be reported.
Time frame: Up to 29 days
Number of Participants with Change from Baseline in Vital Signs Parameters
Number of participants with change from baseline in vital sign parameters (temperature, pulse/heart rate, and blood pressure) will be reported.
Time frame: Up to 29 days
Number of Participants with Change from Baseline in Safety Laboratory Parameters
Number of participants with change from baseline in safety laboratory parameters (including physical examination, clinical laboratory tests and electrocardiograms \[ECG\]) will be reported.
Time frame: Up to 29 days
Plan to share: Yes — Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Data sharing details ↗ · yoda.yale.edu
This study is withdrawn, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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