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Bioequivalence Study of Clopidogrel Tablets 300 mg Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT01621750
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : June 18, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Tracking Information
First Submitted Date  ICMJE June 14, 2012
First Posted Date  ICMJE June 18, 2012
Last Update Posted Date June 18, 2012
Study Start Date  ICMJE August 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2012)
Area under curve(AUC) [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of Clopidogrel Tablets 300 mg Under Fasting Conditions
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fasting
Intervention  ICMJE Drug: Clopidogrel
Clopidogrel Tablets 300 mg
Other Name: Plavix
Study Arms  ICMJE
  • Experimental: Clopidogrel
    Clopidogrel tablets 300 mg of Dr. Reddy's Laboratories Limited
    Intervention: Drug: Clopidogrel
  • Active Comparator: Plavix
    Clopidogrel Tablet 300 mg
    Intervention: Drug: Clopidogrel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2012)
68
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01621750
Other Study ID Numbers  ICMJE 300-08
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Reddy's Laboratories Limited
Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr. Yogesh Gulati, MD Lambda Therapeutic Research Ltd.
PRS Account Dr. Reddy's Laboratories Limited
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP