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CompletedNCT03451487Updated Jul 18, 2023

A Randomized, Single-blind, Parallel Group and Multiple - Dose Design Study

An interventional study of Panadol® and SafeTynadol® in Acetaminophen Toxicity, sponsored by Sinew Pharma Inc.. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-18.

Sponsored by Sinew Pharma Inc. · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study summary

To investigate and compare the possible response of Panadol® and SafeTynadol® formulations in healthy volunteers.

Read the detailed description

Acetaminophen (AAP) is the most popular used analgesic/ antipyretic drug with serious hepatotoxic adverse effects; suicidal or unintentional overdose of AAP-induced hepatotoxicity. Cytochrome P450 2E1 (CYP2E1) is thought contribute to the responsible reactive metabolite N-acetyl-p-benzoquinone (NAPQI) of AAP overdose-induced hepatotoxicity. Pharmaceutical excipients are inactive ingredients that are added to a pharmaceutical compound. The objective of this study was to investigate the possible response of Panadol® (AAP alone) and SafeTynadol® (AAP with various selected excipients combination) formulations, while observing the AAP toxic metabolites (AAP-Cys) circumstances change in healthy volunteers. According to the current safety data, could be potentially develop hepatotoxicity-free AAP new formulation drug.

02

Conditions studied

  • Acetaminophen Toxicity

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Keywords

  • acetaminophen
  • acute liver failure
03

In context

Liver Failure, Acute

100 studies on the registry are indexed under Liver Failure, Acute; 19 are open to participants now.

This study's enrollment of 28 is below the median of 45 across 47 interventional studies indexed under Liver Failure, Acute.

Browse Liver Failure, Acute studies →

Lead sponsor

Sinew Pharma Inc. is the lead sponsor of 8 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  1. Normal healthy adult subjects between 20-50 years of age.
  2. Body weight within 80-120% of ideal body weight. Male: Ideal body weight = (height - 80) * 0.7 Female: Ideal body weight = (height - 70) * 0.6

  3. Acceptable medical history and physical examination including:

    • normal ECG results within six months prior to Period I (or Period III or Period V) dosing.
    • no particular clinical significance in general disease history within two months prior to Period I (or Period III or Period V) dosing.
  4. Acceptable clinical laboratory determinations without significant deviation from normal values within two months prior to Period I (or Period III or Period V) dosing, which includes AST (SGOT), ALT (SGPT), r-GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol, triglyceride (TG) and oral galactose single point (OGSP).
  5. Acceptable hematology within two months prior to the study, which includes hemoglobin, hematocrit, red blood cells, MCV, MCH, MCHC, white blood cells, differential white blood cells and platelets.
  6. Acceptable urinalysis within two months prior to the study, which includes pH, blood, glucose and protein.
  7. Signed the written informed consent to participate in this study.

Exclusion criteria

Exclusion Criteria:

  1. History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 glasses of 120-mL wine or 14 cans of 350-mL beer), or other substance abuse within the prior two years.
  2. A clinically significant disorder involving the allergy, cardiovascular, respiratory, renal, gastrointestinal/hepatic, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
  3. History of allergic response(s) to acetaminophen, mannitol, sucralose or related drugs.
  4. History of clinically significant allergies including drug allergies or allergic bronchial asthma.
  5. Evidence of chronic or acute infectious diseases.
  6. Any clinically significant illness or surgery during the one month prior to Period I (or Period III or Period V) dosing (as determined by the clinical investigator).
  7. Taking any drug known to induce or inhibit hepatic drug metabolism within one month prior to the beginning of the study.
  8. Receiving any investigational drug within one month prior to Period I (or Period III or Period V) dosing.
  9. Taking any prescription medication or any nonprescription medication within two weeks prior to Period I (or Period III or Period V) doing.
  10. Donating greater than 150 ml of blood within two months prior to Period I (or Period III or Period V) dosing or donating plasma (e.g. plasmapheresis) within two weeks prior to Period I (or Period III or Period V) dosing.
  11. Consumption of caffeine, xanthine-containing products (i.e. coffee, tea, caffeine-containing sodas, colas and chocolate, etc.) and/or alcohol within 48 hours prior to days on which dosing is scheduled and during the periods when blood samples are being collected.
  12. Any other medical reason as determined by the clinical investigator.
  13. Subject is pregnant or breastfeeding.
  14. Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
28 participants (actual)

Study arms

  • Placebo comparator
    Reference drug (1000mg)

    Eligible subjects were randomly assigned to either of the two treatment sequence.The evaluable subjects were those who had completed both period I and II. The study was completed when there were at least 12 evaluable subjects. Panadol® oral dosage form (500 mg\*2 tablets = 1000 mg) was orally administered with 240 ml of water once daily in the morning in each of the single-dose study period.

    Drug: Panadol®

  • Experimental
    Test drug (1000mg)

    Eligible subjects were randomly assigned to either of the two treatment sequence.The evaluable subjects were those who had completed both period I and II. The study was completed when there were at least 12 evaluable subjects. SafeTynadol® oral dosage form (500 mg\*2 tablets = 1000 mg) was orally administered with 240 ml of water once daily in the morning in each of the single-dose study period.

    Drug: SafeTynadol®

  • Placebo comparator
    Reference drug (4000mg)

    Eligible subjects were randomly assigned to either of the two treatment sequence.The evaluable subjects were those who had completed both period III and IV. The study was completed when there were at least 12 evaluable subjects. Panadol® oral dosage form (500 mg\*8 tablets = 4000 mg) was orally administered with 240 ml of water once daily in the morning in each of the single-dose study period.

    Drug: Panadol®

  • Experimental
    Test drug (4000mg)

    Eligible subjects were randomly assigned to either of the two treatment sequence.The evaluable subjects were those who had completed both period III and IV. The study was completed when there were at least 12 evaluable subjects. SafeTynadol® oral dosage form (500 mg\*8 tablets = 4000 mg) was orally administered with 240 ml of water once daily in the morning in each of the single-dose study

    Drug: SafeTynadol®

  • Placebo comparator
    Reference drug 2 tablets Q6H (28,000mg)

    Eligible subjects were randomly assigned to either of the two treatment stage.Each treatment will be completed when there are at least 7 evaluable subjects. The evaluable subjects are randomized into period V. Panadol® oral dosage form (500mg\*2 tablets =1000mg) will be orally administered with 240 ml of water every 6 hours daily in each of the multiple-dose study period (Q6H, total 28 dosages, 56 tablets).

    Drug: Panadol®

  • Experimental
    Test drug 2 tablets Q6H (28,000mg)

    Eligible subjects were randomly assigned to either of the two treatment stage.Each treatment will be completed when there are at least 7 evaluable subjects. The evaluable subjects are randomized into period V. SafeTynadol® oral dosage form (500mg\*2 tablets =1000mg) will be orally administered with 240 ml of water every 6 hours daily in each of the multiple-dose study period (Q6H, total 28 dosages, 56 tablets).

    Drug: SafeTynadol®

Interventions

  • DrugPanadol®

    Acetaminophen 500mg Tablet

    Also known as: Acetaminophen

  • DrugSafeTynadol®

    Acetaminophen 500mg Tablet

    Also known as: SNP-810

06

What researchers measure

Primary outcomes

  1. Percentage change from baseline of ALT peak level within study periods

    ALT peak level in blood after administration

    Time frame: Blood samples were collected on days 2-7 (before dosing)

Secondary outcomes

  1. - Incidence of peak ALT elevations > 1X ULN within study periods;

    The blood concentration of ALT.

    Time frame: Day 1-7

  2. - Incidence of peak ALT elevations > 2X ULN within study periods;

    The blood concentration of ALT.

    Time frame: Day 1-7

  3. - Incidence of peak ALT elevations > 3X ULN within study periods;

    The blood concentration of ALT.

    Time frame: Day 1-7

  4. - Incidence of peak ALT elevations > 5X ULN within study periods;

    The blood concentration of ALT.

    Time frame: Day 1-7

  5. - Incidence of peak ALT elevations > 8X ULN within study periods;

    The blood concentration of ALT.

    Time frame: Day 1-7

  6. - Incidence of total bilirubin ≥ 2.5mg/dL within study periods;

    The blood concentration of total bilirubin.

    Time frame: Day 1-7

  7. - Hepatic failure rate (hepatic encephalopathy, ascites, total bilirubin ≥ 2.5mg/dL or liver transplantation) within study periods;

    The blood concentration of hepatic encephalopathy, ascites, total bilirubin.

    Time frame: Day 1-7

  8. - The time-interval weighted area under the curve (AUC) of free plasma acetaminophen-cysteine (AAP-Cys) and AAP-Cys adducts within study periods.

    The blood concentration of free plasma acetaminophen-cysteine (AAP-Cys) and AAP-Cys adducts

    Time frame: Day 1-7

  9. - The time-interval weighted area under the curve (AUC) of ALT level within study periods

    The blood concentration of ALT.

    Time frame: Day 1-7

Other outcomes

  1. - Incidence of adverse events

    Safety

    Time frame: Day 1-12

  2. - Clinical laboratory test

    Concentrations of acetaminophen in plasma

    Time frame: Day 1-12

  3. - Clinical laboratory test

    Concentrations of acetaminophen metabolites (AAP-Glc) in plasma

    Time frame: Day 1-12

  4. - Clinical laboratory test

    Concentrations of acetaminophen metabolites (AAP-Sul) in plasma

    Time frame: Day 1-12

  5. - Clinical laboratory test

    Concentrations of acetaminophen metabolites (GS-AAP) in plasma

    Time frame: Day 1-12

  6. - Clinical laboratory test

    Concentrations of acetaminophen metabolites (AAP-Cys) in plasma

    Time frame: Day 1-12

  7. - Clinical laboratory test

    Concentrations of acetaminophen metabolites (AAP-NAC) in plasma

    Time frame: Day 1-12

  8. - Vital sign

    Heart rate (bpm)

    Time frame: Day 1-12

  9. - Vital sign

    Blood pressure (mmHg)

    Time frame: Day 1-12

  10. - Vital sign

    Temperature (℃)

    Time frame: Day 1-12

07

Study locations

1 site
  • Tri-Service General Hospital
    Taipei, Neihu District 114202, Taiwan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2022 to primary completion in Dec 2022, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 24, 2018
First posted
Mar 1, 2018
StartActual
May 19, 2022
Primary completionActual
Dec 31, 2022
CompletionActual
Dec 31, 2022
Last update
Jul 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03451487
Lead sponsor
Sinew Pharma Inc.
Responsible party
Sponsor
First posted
Mar 1, 2018
Start date
May 19, 2022
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Jul 18, 2023

Study contacts

TeYu Mr Lin, Dr.
principal investigator · Principal Investigator

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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