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Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT00602134
First received: September 19, 2007
Last updated: February 5, 2008
Last verified: February 2008
History of Changes
  Purpose

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:

U.S. FDA Resources

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)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602134

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

No publications provided

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
Study First Received: September 19, 2007
Last Updated: February 5, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013