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A Partial Randomized, Single-blind or Open-label, Dose-escalation With Multiple-dose Design Study to Evaluate the Pharmacokinetics of Acetaminophen and Its Toxic Metabolites With Panadol® and SafeTynadol® in Healthy Volunteers

NCT05563961 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-03-27

No results posted yet for this study

Summary

To investigate and compare the possible response of Panadol® and SafeTynadol® formulations in healthy volunteers and the safety in SafeTynadol® dose-limiting hepatotoxicity.

Conditions

  • Hepatitis
  • Pharmacology

Interventions

DRUG

Panadol®

Reference Drug. Multiple-dose stage: Cohort 1, 2 tablets Q6H (total 4 dosages, 8 tablets or 4,000 mg)

DRUG

SafeTynadol®

Test Drugs. Multiple-dose stage: Cohort 2, 2 tablets Q6H (total 4 dosages, 8 tablets or 4,000 mg) Cohort 3, 3 tablets at first dosage and 2 tablets at second to forth dosage Q6H (total 4 dosages, 9 tablets or 4,500 mg) Cohort 4, 3 tablets at first to second dosage and 2 tablets at third to forth dosage Q6H (total 4 dosages, 10 tablets or 5,000 mg) Cohort 5, 3 tablets Q6H (total 4 dosages, 12 tablets or 6,000 mg) Cohort 6, 4 tablets Q6H (total 4 dosages, 16 tablets or 8,000 mg) Cohort 7, 5 tablets Q6H (total 4 dosages, 20 tablets or 10,000 mg) Cohort 8, 6 tablets Q6H (total 4 dosages, 24 tablets or 12,000 mg)

Sponsors & Collaborators

  • Sinew Pharma Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-28
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05563961 on ClinicalTrials.gov