Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions

NCT ID: NCT00602134

Last Updated: 2018-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2002-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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6-Mercaptopurine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Roxane Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Roxane Laboratories, Inc.

Principal Investigators

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Mark J Allison, MD

Role: PRINCIPAL_INVESTIGATOR

MDS Pharma Services

Locations

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MDS Pharma Services

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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439-09

Identifier Type: -

Identifier Source: org_study_id

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