NCT00648336

CompletedPhase 1

Fasting Study of Mercaptopurine 50 mg and Purinethol® Tablet...

Mylan Pharmaceuticals Inc Source

Compare

Other study identifiers

Sponsor study identifier

MERC-0360

Study Type

interventional

Actual enrollment (reported)

60

Locations

1 country

Sites

1

Timeline

Study Start

November 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2003

Actual (reported)

Study Completion

December 2003

Actual (reported)

Brief Summary

The objective of this study was to investigate the bioequivalence of Mylan's mercaptopurine 50 mg tablets to Gate's Purinethol® 50 mg tablets following a single, oral 50 mg (1 x 50 mg) dose administered under fasting conditions.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 60 participants
Study completion date: December 2003
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2003
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
December 2003
Actual (reported)
Study Completion
December 2003
Actual (reported)
First Submitted
March 30, 2008
Actual (reported)
First Posted
April 1, 2008
Actual (reported)

Last Updated: April 24, 2024
Status Verified: April 2024
Last Update Submitted: April 22, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

Bioequivalence
within 30 days

Study Arms (2)

1

EXPERIMENTAL

Mercaptopurine 50 mg

Drug: Mercaptopurine 50 mg

2

ACTIVE COMPARATOR

Purinethol® Tablets 50 mg

Drug: Purinethol® Tablets 50 mg

Interventions

Mercaptopurine 50 mgDrug

50mg, single dose fasting

1

Purinethol® Tablets 50 mgDrug

50mg, single dose fasting

2

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age: 18 years and older.
Sex: Male

Sponsors & Collaborators

Mylan Pharmaceuticals Inc
Industrylead

Study Sites (1)

PRACS Institute, Ltd.

Fargo, North Dakota, 58104, United States

MeSH Terms

Interventions

Mercaptopurine

Intervention Hierarchy (Ancestors)

Sulfhydryl CompoundsSulfur CompoundsOrganic ChemicalsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

James D Carlson, Pharm. D.
PRACS Institute Ltd.
PRINCIPAL INVESTIGATOR

Enrollment

60 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

March 30, 2008

First Posted

April 1, 2008

Study Start

November 2003

Date type not reported

This date has not been verified as actual or estimated.

NCT00649532

Fasting Study of Ondansetron Tablets 24 mg and Zofran® Tablets 24 mg

Phase 1Completed

NCT00650208

Fasting Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg

Phase 1Completed

NCT00650195

Fasting Study of Metolazone Tablets 10 mg and Zaroloxyn® Tablets 10 mg

Phase 1Completed

NCT00647777

Food Study of Olanzapine Tablets 5 mg and Zyprexa® Tablets 5 mg

Phase 1Completed

NCT00649233

Food Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg to Lopressor HCT® Tablets 100/50 mg

Phase 1Completed

NCT00649441

Fasting Study of Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Accuretic™ Tablets 20 mg/25 mg

Phase 1Completed

Volunteers are to be sterile (documentation required) or during the course of the study, from study screen until 3 months after study exit, non-sterile male volunteers must use a spermicide-containing barrier method of contraception to prevent the pregnancy of their sexual partner. This advice should be documented in the informed consent form.

Weight: At least 60 kg (132 lbs.) and within 15% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).

All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, 12-lead ECG, hepatitis B and hepatitis C tests, HIV test, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.

You may not qualify if:

Institutionalized subjects will not be used.
Social Habits:
Use of any tobacco products within 1 year of the start of the study.
Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
Ingestion of any vitamin or herbal supplements within 7 days prior to the initial dose of the study medication.
Any recent, significant change in dietary or exercise habits.
History of drug and/or alcohol abuse within 1 year of the start of the study.
A positive result for any drug in the urine drug screen.
Medications:
Use of any medication within the 14 days prior to the initial dose of study medication.
Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
Use of allopurinol or aminosalicylates (e.g. olsalazine, mesalamine, sulfasalazine) within 3 months of the start of the study.
Diseases:
History of any significant chronic disease and/or hepatitis.
Acute illness at the time of either the pre-study medical evaluation or dosing.
+11 more criteria

Contact the study team to confirm eligibility.

Primary Completion

December 2003

Actual (reported)

Study Completion

December 2003

Actual (reported)

Last Updated

April 24, 2024

Record last verified: 2024-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00648336
Data provider: ClinicalTrials.gov
Source updated: 2024-04-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:18 UTC

Locations

US(1)

Fasting Study of Mercaptopurine 50 mg and Purinethol® Tablets 50 mg

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations