Back to resultsBioequivalence Study of 6-Mercaptopurine Under Fasting Conditions
Primary Purpose
Acute Lymphoblastic Leukemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
6-Mercaptopurine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia
Eligibility Criteria
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.
Sites / Locations
- MDS Pharma Services
Outcomes
Primary Outcome Measures
Bioequivalence
Secondary Outcome Measures
Full Information
NCT ID
NCT00602134
First Posted
September 19, 2007
Last Updated
January 19, 2018
Sponsor
Roxane Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT00602134
Brief Title
Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
November 2002 (Actual)
Study Completion Date
November 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Roxane Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
6-Mercaptopurine
Primary Outcome Measure Information:
Title
Bioequivalence
Time Frame
Baseline, two period, 3 day washout
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J Allison, MD
Organizational Affiliation
MDS Pharma Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
MDS Pharma Services
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85044
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions
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