Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions
Not Applicable
Completed
- Conditions
- Acute Lymphoblastic Leukemia
- Registration Number
- NCT00602134
- Lead Sponsor
- Roxane Laboratories
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 54
Inclusion Criteria
- No clinically significant abnormal findings on physical examination, medical history, or clinical laboratory results.
- Must voluntarily consent.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Bioequivalence Baseline, two period, 3 day washout
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
MDS Pharma Services
🇺🇸Phoenix, Arizona, United States