- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01621763
Bioequivalence Study of Clopidogrel Tablets 300 mg Under Fed Conditions
June 22, 2012 updated by: Dr. Reddy's Laboratories Limited
An Open Label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Single-dose, Crossover Oral Bioequivalence Study of Clopidogrel 300 mg Tablets of Dr. Reddy's India and Plavix® 300 mg Tablets Under Fed Conditions
To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsor's formulation (Clopidogrel Bisulfate 300 mg Tablets) with respect to the reference formulation (Plavix® 300 mg tablets) in healthy, adult, human, male subjects under fed conditions and to assess the bioequivalence.
Study Overview
Detailed Description
An open label, balanced, randomized, two treatment, two sequence, two period, single-dose, crossover oral bioequivalence study of Clopidogrel Bisulfate 300 mg Tablets of Dr. Reddy's Laboratories Ltd., India and Plavix® (Clopidogrel Bisulfate) 300 mg Tablets of Bristol-Myers Squibb/Sanofi pharmaceuticals partnership Bridgewater, NJ 0880750086441, USA, in healthy, adult, human male subjects under fed conditions.
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gujrat
-
Ahmedabad, Gujrat, India
- Lambda Therapeutic Research Ltd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy adult human male volunteers between 18 and 55 years of age (both inclusive) living in and around Ahmedabad city of western part of India.
- Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg/height in m2.
- Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (postero-anterior view) recordings.
- Able to understand and comply with the study procedures, in the opinion of the Principal investigator.
- Able to give voluntary written consent for participation in the trial.
Exclusion Criteria:
- Known hypersensitivity or idiosyncratic reaction to Clopidogrel or any related drug.
- History or presence of 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 any medication at any time in 14 days prior to the dosing of Period-I. In any such case subject selection was at the discretion of the Principal Investigator.
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria.
- A recent history of alcoholism (less than 2 years) or daily consumption of moderate (180 mL / day) alcohol use or consumption of alcohol within 48 hours prior to receiving the study medicine.
- The presence of clinically significant abnormal laboratory values including APTT and PT during screening.
- Consumption of grapefruit and/or grapefruit products within 48hrs prior to dosing.
- Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- History of psychiatric disorders.
- A history of difficulty in donating blood.
- Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of IP.
Note: In case the blood loss was less than or equal to 200 mL; subject was enrolled 60 days after blood donation.
- Smokers, who smoked more than 10 cigarettes / day or inability to abstain from smoking during the study.
- A positive hepatitis screen including hepatitis B surface antigen, 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 subject had participated in a study in which blood loss was less than or equal to 200 mL, subject was dosed 60 days after the last sample of previous study.
- An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study medication and throughout the subjects' participation in the study. In any such case subject selection was at the discretion of the Principal Investigator.
- Any history of peptic ulcer disease, which include gastric & duodenal ulcer or any other bleeding disorders.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Clopidogrel
Clopidogrel tablets 300 mg of Dr. Reddy's Laboratories Limited
|
Clopidogrel Tablets 300 mg
Other Names:
|
Active Comparator: Plavix
Clopidogrel Tablet 300 mg
|
Clopidogrel Tablets 300 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under curve(AUC)
Time Frame: at pre-dose 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 16.00, 20.00, 24.00, 36.00 and 48.00 hours post dose
|
at pre-dose 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 16.00, 20.00, 24.00, 36.00 and 48.00 hours post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dr. Dimple Shah, MD, Lambda Therapeutic Research Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
June 14, 2012
First Submitted That Met QC Criteria
June 14, 2012
First Posted (Estimate)
June 18, 2012
Study Record Updates
Last Update Posted (Estimate)
June 25, 2012
Last Update Submitted That Met QC Criteria
June 22, 2012
Last Verified
September 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 305-08
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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