Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions

This study has been completed.
Information provided by:
Roxane Laboratories Identifier:
First received: September 19, 2007
Last updated: February 5, 2008
Last verified: February 2008
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.

Condition Intervention
Acute Lymphoblastic Leukemia
Drug: 6-Mercaptopurine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: Baseline, two period, 3 day washout ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: November 2002
Study Completion Date: November 2002
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT00602134

United States, Arizona
MDS Pharma Services
Phoenix, Arizona, United States, 85044
Sponsors and Collaborators
Roxane Laboratories
Principal Investigator: Mark J Allison, MD MDS Pharma Services
  More Information

Responsible Party: Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc. Identifier: NCT00602134     History of Changes
Other Study ID Numbers: 439-09 
Study First Received: September 19, 2007
Last Updated: February 5, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Physiological Effects of Drugs processed this record on May 26, 2016