Bioequivalence Study of Torrent Pharmaceuticals Ltd's Clopidogrel Tablets Under Fasting Conditions

Healthy Clinical Trial

Official title:

An Open Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Crossover, Single-Dose Bioequivalence Study of Clopidogrel Tablets USP 75mg [Test Formulation, Torrent Pharmaceutical Limited., India] Versus Plavix® (Clopidogrel Bisulfate Tablets) 75mg [Reference Formulation, Bristol-Myers Squibb/Sanofi Pharmaceuticals, USA], in Healthy Human Volunteers Under Fasting Condition.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01630642
• Other study ID #: PK-08-043
• Status: Completed
• Phase: Phase 1
• First received: June 26, 2012
• Last updated: June 26, 2012

Study information

• Verified date: June 2012
• Source: Torrent Pharmaceuticals Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaIndia: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial Summary

Objective:

Primary objective of the present study was to compare the single dose bioavailability of Torrent's Clopidogrel Tablets USP 1 × 75 mg and Plavix® (Clopidogrel Bisulfate) Tablets 1 × 75 mg of Bristol-Myers Squibb/Sanofi Pharmaceuticals, USA. Dosing periods were separated by a washout period of 7 days.

Study Design:

Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

The volunteers were included in the study based on the following criteria:

• Sex: male.

• Age: 18 - 45 years.

• Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.

• Healthy and willing to participate in the study.

• Volunteer willing to adhere to the protocol requirements and to provide written informed consent.

• Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

The volunteers were excluded from the study based on the following criteria:

• Clinically relevant abnormalities in the results of the laboratory screening evaluation.

• Clinically significant abnormal ECG or Chest X-ray.

• Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.

• Pulse rate less than 50/minute or more than 100/minute.

• Oral temperature less than 95°P or more than 98.6°P.

• Respiratory rate less than 12/minute or more than 20/minute

• History of allergy to the test drug or any drug chemically similar to the drug under investigation.

• History of alcohol or drug abuse

• Positive breath alcohol test

• Recent history of kidney or liver dysfunction.

• History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.

• Volunteers suffering from any chronic illness such as arthritis, asthma etc.

• History of heart failure.

• HIV, HCV, HBsAg positive volunteers.

• Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - Cocaine positive volunteers based on urine test.

• Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.

• Administration of any study drug in the period 0 to 3 months before entry to the study.

• History of significant blood loss due to any reason, including blood donation in the past 3 months.

• History of pre-existing bleeding disorder.

• Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.

• Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.

Study Design

N/A

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Torrent's Clopidogrel Tablets USP 75 mg

Locations

Country	Name	City	State
India	Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.,	Village Bhat, Gandhinagar	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Torrent Pharmaceuticals Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bioequivalence based on Composite of Pharmacokinetics	bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.		No