Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions

Roxane Laboratories

Status: Completed

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: 6-Mercaptopurine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00602134

439-09

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)