Bioequivalence Study of Clopidogrel Tablets 300 mg Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01621763
First received: June 14, 2012
Last updated: June 22, 2012
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Clopidogrel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: September 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clopidogrel
Clopidogrel tablets 300 mg of Dr. Reddy's Laboratories Limited
Drug: Clopidogrel
Clopidogrel Tablets 300 mg
Other Name: Plavix
Active Comparator: Plavix
Clopidogrel Tablet 300 mg
Drug: Clopidogrel
Clopidogrel Tablets 300 mg
Other Name: Plavix

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01621763

Locations
India
Lambda Therapeutic Research Ltd
Ahmedabad, Gujrat, India
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Dr. Dimple Shah, MD Lambda Therapeutic Research Ltd.,
  More Information

No publications provided

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01621763     History of Changes
Other Study ID Numbers: 305-08
Study First Received: June 14, 2012
Last Updated: June 22, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 22, 2014