Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions

Not Applicable

Completed

• Conditions: Acute Lymphoblastic Leukemia

• Registration Number: NCT00602134
• Lead Sponsor: Roxane Laboratories

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2002-11
• Study Completion: 2002-11
• Study First Submitted: 2007-09-19
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-01-28
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Bioequivalence	Baseline, two period, 3 day washout

Trial Locations

Locations (1)

MDS Pharma Services; 🇺🇸 Phoenix, Arizona, United States