Bioequivalence Study of Clopidogrel Tablets 300 mg Under Fasting Conditions

NCT01621750 | Completed Phase 1 DMC

• 1 other identifier: 300-08
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fasting

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Clopidogrel

EXPERIMENTAL

Clopidogrel tablets 300 mg of Dr. Reddy's Laboratories Limited

Drug: Clopidogrel

Plavix

ACTIVE COMPARATOR

Clopidogrel Tablet 300 mg

Drug: Clopidogrel

Interventions

Clopidogrel DRUG

Clopidogrel Tablets 300 mg

Also known as: Plavix

Clopidogrel; Plavix

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Lambda Therapeutic Research Ltd

Ahmedabad, Gujarat, India

Location

MeSH Terms

Conditions

Fasting

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dr. Yogesh Gulati, MD

  Lambda Therapeutic Research Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: June 18, 2012
• Study Start: August 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: June 18, 2012

Record last verified: 2008-08

Locations

IN (1)