Trials / Completed
CompletedNCT00602134
Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions
A Pharmacokinetic Study to Assess the Single-Dose Bioequivalence of a Potential Generic Formulation of a 6-Mercaptopurine 50 mg Tablet Compared to a Marketed 6-Mercaptopurine 50 mg Tablet, Purinethol®, When Administered to Healthy Male Subjects, in the Fasted State
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Roxane Laboratories · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study was to assess the bioequivalence of a potential generic 6-mercaptopurine 50 mg tablet formulation compared with GlaxoSmithKline Purinethol® (mercaptopurine) 50-mg scored tablets following a single 50 mg oral dose administered in the fasted state.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 6-Mercaptopurine |
Timeline
- Start date
- 2002-11-01
- Primary completion
- 2002-11-01
- Completion
- 2002-11-01
- First posted
- 2008-01-28
- Last updated
- 2018-01-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00602134. Inclusion in this directory is not an endorsement.