Status:
COMPLETED
Fasting Study of Mercaptopurine 50 mg and Purinethol® Tablets 50 mg
Lead Sponsor:
Mylan Pharmaceuticals Inc
Conditions:
Healthy
Eligibility:
MALE
18+ years
Phase:
PHASE1
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 administer...
Eligibility Criteria
Inclusion
- Age: 18 years and older.
- Sex: Male
- 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.
Exclusion
- 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.
- A positive HIV, hepatitis B, or hepatitis C test.
- Abnormal and clinically significant laboratory test results:
- Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- Abnormal and clinically relevant ECG tracing.
- Abnormal liver function tests (i.e. ALT (SGPT), AST (SGOT), alkaline phosphatase, bilirubin).
- Donation or loss of a significant volume of blood or plasma (\> 450 mL) within 28 days prior to the initial dose of study medication.
- Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
- Allergy or hypersensitivity to mercaptopurine or other related products.
- History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
- Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
- Family history of a deficiency in the enzyme thiopurine methyltransferase.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00648336
Start Date
November 1 2003
End Date
December 1 2003
Last Update
April 24 2024
Active Locations (1)
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1
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104