NCT04214691

A Study of Newly Formulated Tylenol Tablet (Acetaminophen) and Tylenol 8 Hour (H) Extended Release (ER) Tablet (Acetaminophen) in Healthy Participants

A Single-dose, Open-label, Randomized, Two-treatment, Two-period, Crossover Study in Healthy Subjects to Assess the Bioequivalence of the Newly Formulated Tylenol® Tablet (Acetaminophen) to the Tylenol® 8H ER Tablet (Acetaminophen) Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the bioequivalence of the newly formulated Tylenol tablet (acetaminophen 650 milligram \[mg\]) with respect to the Tylenol 8 hour (H) extended-release (ER) tablet (acetaminophen 650 mg) in healthy participants under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Acetaminophen	Acetaminophen tablet will be administered orally in treatment sequence 1 and 2.

Timeline

• Start date: 2019-12-17
• Primary completion: 2020-01-16
• Completion: 2020-02-07
• First posted: 2020-01-02
• Last updated: 2025-04-27

Locations

1 site across 1 country: South Korea