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Sponsored by: |
Roxane Laboratories |
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Information provided by: | Roxane Laboratories |
ClinicalTrials.gov Identifier: | NCT00602134 |
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 |
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Acute Lymphoblastic Leukemia |
Drug: 6-Mercaptopurine |
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 |
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:
Exclusion Criteria:
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 |
Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma |
6-Mercaptopurine Healthy Lymphoproliferative Disorders Lymphoma |
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 |