Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions
Information source: Roxane Laboratories
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Lymphoblastic Leukemia
Intervention: 6-Mercaptopurine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Roxane Laboratories Official(s) and/or principal investigator(s): Mark J Allison, MD, Principal Investigator, Affiliation: MDS Pharma Services
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
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.
Locations and Contacts
MDS Pharma Services, Phoenix, Arizona 85044, United States
Additional Information
Starting date: November 2002
Last updated: February 5, 2008
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