Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions

Roxane Laboratories54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Lymphoblastic Leukemia

Interventions

6-MercaptopurineDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

MDS Pharma Services

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Bioequivalence

Time frame: Baseline, two period, 3 day washout

Data from ClinicalTrials.gov

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