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Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00602134
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : February 8, 2008
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia Drug: 6-Mercaptopurine

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : November 2002
Primary Completion Date : November 2002
Study Completion Date : November 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Bioequivalence [ Time Frame: Baseline, two period, 3 day washout ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.
ClinicalTrials.gov Identifier: NCT00602134     History of Changes
Other Study ID Numbers: 439-09
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: February 8, 2008
Last Verified: February 2008

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