Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/25/2018 |
| Start Date: | November 2002 |
| End Date: | November 2002 |
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
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.
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.
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.
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