Status:
COMPLETED
Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fasting Conditions
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddy's Laboratories limited, ...
Detailed Description
This was an open-label, balanced, randomized, two-treatment, two-sequence, two-period, single dose, crossover bioequivalence study in healthy, adult, human, male subjects under Fasting conditions. 72 ...
Eligibility Criteria
Inclusion
- Subjects aged between 18 and 50 years (including both).
- Subjects' weight within the normal range according to normal values for the Body
- Mass Index (1 8.5 to 24.9 kg/m2) with minimum of 50 kg weight.
- Subjects with clinically acceptable normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.
- Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- Subjects having clinically acceptable chest X-Ray (PIA view).
- Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- Subjects having negative alcohol breath test.
- Subjects willing to adhere to the protocol requirements and to provide written informed consent.
Exclusion
- The subjects were excluded from the study, if they meet any of the following criteria:
- Hypersensitivity to Mycophenolate Mofetil or related drugs.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- History or presence of significant alcoholism or drug abuse in the past one year.
- History or presence of significant smoking (more than 10 cigarettes day or consumption of tobacco products).
- History or presence of asthma, urticaria or other significant allergic reactions.
- History or presence of significant gastric and/or duodenal ulceration.
- History or presence of glaucoma, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm and myasthenia gravis.
- History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- History or presence of cancer.
- Difficulty with donating blood.
- Difficulty in swallowing solids like tablets or capsules.
- Use of any prescribed medication or OTC medicinal products during the last two week prior to initiation of study.
- Major illness during 3 months before screening.
- Participation in a drug research study within past 3 months.
- Donation of blood in the past 3 months before screening.
- Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
- History or presence of significant easy bruising or bleeding.
- History or presence of significant recent trauma.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01513044
Start Date
January 1 2009
End Date
January 1 2009
Last Update
January 20 2012
Active Locations (1)
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1
veeda clinical research Pvt. Ltd
Ahmedabad, Gujarat, India, 3 80 015