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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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