Overview

Bioequivalence Study of Clopidogrel Tablets 300 mg Under Fasting Conditions

Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Treatments:
Clopidogrel
Ticlopidine
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.