Trials / Completed
CompletedNCT04230252
A Study of the Newly Formulated Tylenol Tablet (Acetaminophen) to the 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 Fasting 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 mg) with respect to the Tylenol 8 Hour (H) Extended Release (ER) tablet (acetaminophen 650 mg) in healthy participants under fasting conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acetaminophen | Acetaminophen tablet will be administered orally in treatment sequence 1 and 2. |
Timeline
- Start date
- 2020-01-07
- Primary completion
- 2020-02-10
- Completion
- 2020-03-23
- First posted
- 2020-01-18
- Last updated
- 2025-04-27
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04230252. Inclusion in this directory is not an endorsement.