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Bioequivalence Study of Torrent Pharmaceuticals Ltd's Clopidogrel Tablets Under Fed Condition

Primary Purpose

Healthy

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Torrent's Clopidogrel Tablets USP 75 mg
Sponsored by
Torrent Pharmaceuticals Limited
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Healthy

Eligibility Criteria

18 Years - 55 Years (Adult)Male

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.

Sites / Locations

  • Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.,

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 26, 2012
Last Updated
June 27, 2012
Sponsor
Torrent Pharmaceuticals Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01630915
Brief Title
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Clopidogrel Tablets Under Fed Condition
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 Fed Condition
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Torrent Pharmaceuticals Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Torrent's Clopidogrel Tablets USP 75 mg
Primary Outcome Measure Information:
Title
bioequivalence based on Composite of Pharmacokinetics
Description
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Eligibility Criteria
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.
Facility Information:
Facility Name
Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.,
City
Village Bhat, Gandhinagar
State/Province
Gujarat
Country
India

12. IPD Sharing Statement

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Bioequivalence Study of Torrent Pharmaceuticals Ltd's Clopidogrel Tablets Under Fed Condition

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