drugset / Trial / NCT04214691

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

NCT04214691

Phase 1 Completed 30 enrolled Janssen Korea, Ltd., Korea
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2019-12-17
Primary completion
2020-01-16
Completion
2020-02-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 650 mg Oral

Indications

No indication recorded.