Bioequivalence Study of Clopidogrel Tablets 300 mg Under Fasting Conditions

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 Under Fasting 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 fasting conditions and to assess the bioequivalence.

Study Overview

• Status: Completed
• Conditions: Fasting
• Intervention / Treatment: Drug: Clopidogrel

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 fasting conditions.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Gujrat
    • Ahmedabad, Gujrat, India
      • Lambda Therapeutic Research Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• 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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Clopidogrel; Clopidogrel tablets 300 mg of Dr. Reddy's Laboratories Limited	Drug: Clopidogrel; Clopidogrel Tablets 300 mg; Other Names: Plavix
ACTIVE_COMPARATOR: Plavix; Clopidogrel Tablet 300 mg	Drug: Clopidogrel; Clopidogrel Tablets 300 mg; Other Names: Plavix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under curve(AUC)	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

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Dr. Yogesh Gulati, MD, Lambda Therapeutic Research Ltd.

Study record dates

Study Major Dates

• Study Start: August 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 18, 2012
• Last Update Submitted That Met QC Criteria: June 14, 2012
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: 300-08