Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions - Full Text View

Sponsored by:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00602134

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

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Mercaptopurine 6-Mercaptopurine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
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

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

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

Study placed in the following topic categories:

Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma

6-Mercaptopurine
Healthy
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents

Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009