Bioequivalence Study of 6-Mercaptopurine Under Fasting Co... | NCT00602134

Studies
Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions

NCT00602134

Sponsor

Roxane Laboratories

Status

Completed

Last Update Posted

Jan 23, 2018Actual

Enrollment

54Actual

Phase

Not Applicable

Conditions

Acute Lymphoblastic Leukemia

Interventions

6-Mercaptopurine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2002

Primary Completion Date

Nov 2002Actual

Completion Date

Nov 2002Actual

First Submitted Date

Sep 19, 2007

First Submission Date that Met QC Criteria

Jan 25, 2008

First Posted Date

Jan 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2018

Last Update Posted Date

Jan 23, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Name	Type	Description	Arm Group Labels	Other Names
6-Mercaptopurine	Drug

Measure	Description	Time Frame
Bioequivalence		Baseline, two period, 3 day washout

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark J Allison, MD	MDS Pharma Services	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MDS Pharma Services		Phoenix	Arizona	85044	United States

Condition Browse Module

MeSH Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015122	Mercaptopurine

Ancestor Terms

ID	Term
D013438	Sulfhydryl Compounds
D013457	Sulfur Compounds
D009930	Organic Chemicals
D011687	Purines

Browse Leaves

Not provided

Browse Branches

Not provided