Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions

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.

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.