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Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions

Information source: Roxane Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Lymphoblastic Leukemia

Intervention: 6-Mercaptopurine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Roxane Laboratories

Official(s) and/or principal investigator(s):
Mark J Allison, MD, Principal Investigator, Affiliation: MDS Pharma Services


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bioequivalence


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.


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


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

- Must not be currently using allopurinol.

Locations and Contacts

MDS Pharma Services, Phoenix, Arizona 85044, United States
Additional Information

Starting date: November 2002
Last updated: February 5, 2008

Page last updated: August 23, 2015

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