- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01283841
Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablets of Dr.Reddy's Laboratories Limited Under Fasting Conditions
An Open-label, Balanced, Randomized, Two-treatment, Four-period, Two Sequence, Single Dose, Replicate, Crossover, Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablet of Dr. Reddy's Laboratories Limited Comparing With That of Cellcept 500 mg Tablet of Roche Laboratories in Healthy, Adult,Human, Male Subjects Under Fasting Conditions.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ahmedabad
-
Bodakdev, Ahmedabad, India, 3 80 054
- Lambda Therapeutic Research Ltd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy males between 18-45 years of age (both inclusive) living in and around Mumbai city of western part of India.
- Having a weight more than or equal to 50 Kg and having a Body Mass Index (BMI)between 18.5-24.9 (both inclusive), calculated as weight in kg / height in m2.
- Having no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and chest X-ray (postero-anterior view) recordings.
- Able to comply with the study procedures, in the opinion of the Principal Investigator.
- Able to give written consent for participation in the trial.
Exclusion Criteria:
- Known hypersensitivity or idiosyncratic reaction to Mycophenolate Mofetil or any drug.
- Any disease or condition which might compromise the haemopoietic, renal, hepatic,endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological,gastrointestinal or any other body system.
- Ingestion of a medicine at any time with in 14 days before dosing in Period-I. In any such case subject selection will be at the discretion of the Principal Investigator /Medical Expert.
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria.
- A recent history of alcoholism (<2 years) or of moderate (180 mL / day) alcohol use, or consumption of alcohol within 48 hours of receiving study medicine.
- Smokers, who had a habit of smoking 10 or more than 10 cigarettes / day or could, not abstain from smoking during the study.
- The presence of clinically significant abnormal laboratory values during screening.
- Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug scan.
- History of psychiatric disorders.
- A history of difficulty with donating blood.
Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of the study medicine or during the study.
Note: In case the blood loss was ≤ 200 mL, the subject was enrolled 60 days after blood donation.
- A positive hepatitis screen including hepatitis B surface antigen and anti-HCV antibodies.
- A positive test result for HIV antibody and / or syphilis.
The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study medication. Elimination half-life of the study drug was taken into consideration for inclusion of the subject in the study.
Note: If the subject had participated in a study in which blood loss was ≤ 200 mL, the subject was dosed 60 days after the collection of last sample in the previous study.
- An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study medicine and throughout the subject's participation in the study. In any such case selection of the subject will be at the discretion of the Principal Investigator/Medical Expert.
- Uric acid parameters at the time of screening are not within clinically acceptable range.
- History of gout and renal calculi.
- Sitting blood pressure less than 100/60 mm Hg at the time of screening.
- Haemoglobin less than 13 gm/dL at the time of screening.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mycophenolate Mofetil
Mycophenolate Mofetil 500 mg tablets of Dr. Reddy's Laboratories Limited
|
Mycophenolate Mofetil 500 mg tablets
Other Names:
|
Active Comparator: Cellcept
Cellcept 500 mg tablets of Roche Laboratories Inc.
|
Mycophenolate Mofetil 500 mg tablets
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bioequivalence on Cmax and AUC parameters
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: T Gitanjali, MD, Lambda Therapeutic Research Ltd.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 291-07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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