NCT00648336

Fasting Study of Mercaptopurine 50 mg and Purinethol® Tablets 50 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Mercaptopurine (50 mg; Mylan) and Purinethol® Tablets (50 mg; Gate) in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's mercaptopurine 50 mg tablets to Gate's Purinethol® 50 mg tablets following a single, oral 50 mg (1 x 50 mg) dose administered under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Mercaptopurine 50 mg	50mg, single dose fasting
DRUG	Purinethol® Tablets 50 mg	50mg, single dose fasting

Timeline

• Start date: 2003-11-01
• Primary completion: 2003-12-01
• Completion: 2003-12-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States