NCT03451487

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

A Randomized, Single-blind, Parallel Group and Multiple - Dose Design Study to Evaluate the Pharmacokinetics of Acetaminophen and Its Toxic Metabolites With Panadol® and Various Formulations of SafeTynadol® in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Sinew Pharma Inc. · Industry
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Acetaminophen Toxicity

Interventions

Type	Name	Description
DRUG	Panadol®	Acetaminophen 500mg Tablet
DRUG	SafeTynadol®	Acetaminophen 500mg Tablet

Timeline

• Start date: 2022-05-19
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2018-03-01
• Last updated: 2023-07-18

Locations

1 site across 1 country: Taiwan