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

NARecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

October 28, 2022

Primary Completion Date

June 30, 2024

Study Completion Date

December 31, 2024

Conditions
HepatitisPharmacology
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)"

Trial Locations (1)

114202

RECRUITING

Tri-Service General Hospital, Taipei

All Listed Sponsors
lead

Sinew Pharma Inc.

INDUSTRY