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NCT00602134 Clinical Trial

Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions

Acute Lymphoblastic Leukemia Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00602134
Other study ID # 439-09
Secondary ID
Status Completed
Phase N/A
First received September 19, 2007
Last updated January 19, 2018
Start date November 2002
Est. completion date November 2002

Study information
Verified date January 2018
Source West-Ward Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date November 2002
Est. primary completion date November 2002
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 6-Mercaptopurine

Locations
Country Name City State
United States MDS Pharma Services Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bioequivalence Baseline, two period, 3 day washout
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