Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions

• Status: Completed
• Trial end date: 2002-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Roxane Laboratories
• Treatments: 6-Mercaptopurine; Mercaptopurine

Criteria

Inclusion Criteria:

• No clinically significant abnormal findings on physical examination, medical history, or clinical laboratory results.

• Must voluntarily consent.

Exclusion Criteria:

• Must not have a known history of thiopurine methyltransferase deficiency or family history.

• Must not have a history of elevated uric acid or gout.

• Must not be currently using allopurinol.