Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions

Completed · Not applicable

Conditions studied: Acute Lymphoblastic Leukemia

In brief

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.

Key facts

Study ID

NCT00602134

Run by

Roxane Laboratories

People needed

54

Starts

2002-11-01

Expected to finish

2002-11-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• No clinically significant abnormal findings on physical examination, medical history, or clinical laboratory results.
• Must voluntarily consent.

You may not qualify if…

• 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.

Where it is running

• MDS Pharma Services — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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