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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00602134

Enrollment

Registered

2008-01-28

Start date

2002-11-30

Completion date

2002-11-30

Last updated

2018-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia

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.

Interventions

DRUG6-Mercaptopurine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Bioequivalence	Baseline, two period, 3 day washout

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026