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Bioequivalence Study of Clopidogrel Tablets 75 mg of Dr. Reddy's Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01506713
First received: January 6, 2012
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Laboratories Ltd, clopidogrel and Bristol-Myers Squibb Company, USA Plavix®, clopidogrel 75 mg tablet under fasting condition.


Condition Intervention Phase
Fasting
Drug: Clopidogrel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Open-label, 2-Way Crossover, Bioequivalence Study of Clopidogrel 75 mg Tablet With Plavix® 75 mg In Healthy Subjects Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence is based on Cmax and AUC parameters [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: September 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clopidogrel
Clopidogrel tablets 75 mg of Dr. Reddy's Laboratories Limited
Drug: Clopidogrel
Clopidogrel Tablets 75 mg
Other Name: Plavix
Active Comparator: Plavix
Clopidogrel Tablet 75 mg
Drug: Clopidogrel
Clopidogrel Tablets 75 mg
Other Name: Plavix

Detailed Description:

Randomized, Open-label, 2-Way Crossover, Bioequivalence Study of Clopidogrel 75 mg Tablet (Dr. Reddy's Laboratories Ltd., India) and Plavix® (Bristol-Myers Squibb Company, USA) Following a 75 mg Dose In Healthy Subjects Under Fasting Conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may use various media types (e.g. radio, newspaper, Anapharm Web site, Anapharm volunteers' database). Subjects must meet all of the following criteria to be included in the study:

  • Male or female, non-smoker, ≥18 and ≤55 years of age.
  • Medically healthy with clinically normal laboratory profile, vital signs and ECG.
  • Capable of consent.
  • BMI ≥19.0 and <30.0

Exclusion Criteria:

Subjects to whom any of the following applies will be excluded from the study:

  • Clinically significant illness or surgery within 4 weeks prior to dosing.
  • Any clinically significant abnormality or abnormal laboratory test results found during medical screening.
  • Any reason which, in the opinion of the Clinical Sub-.investigator, would prevent the subject from participating in the study.
  • Positive test for hepatitis B, hepatitis C, or HIV at screening.
  • ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or• heart rate less than 50 or over J00 bpm) at screening.
  • History of significant alcohol abuse or drug abuse within one year prior to the screening visit.
  • Regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [J Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]), or positive alcohol breath test at screening.
  • Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine (PCP] and -crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
  • History of allergic reactions to clopidogrel or other related drugs.
  • Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fIuoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
  • Use of an investigational drug or participation in an investigational study within 30 days prior to dosing.
  • Clinically significant history or presence of any gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
  • Any clinically significant history or presence of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, or metabolic disease.
  • Use of prescription medication within 14 days prior to administration of study medication or over-the counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption and hormonal contraceptives.
  • Difficulty to swallow study medication.
  • Use of any tobacco products in the 3 months preceding drug administration.
  • Any food allergy, intolerance, restriction or special diet that, in the opinion of the Clinical Sub-Investigator, could contraindicate the subject's participation in this study.
  • A depot injection or an implant of any drug (other than hormonal contraceptives) within 3 months prior to administration of study medication.
  • Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:
  • 50 mL to 499 mL of whole blood within 30 days,
  • more than 499 mL of whole blood within 56 days prior to drug administration.
  • Positive urine pregnancy test at screening.
  • Breast-feeding subject.
  • Female subjects of childbearing potential having unprotected sexual intercourse with any non-sterile male partner (i.e. male who has not been sterilized by vasectomy for at least 6 months) within 14 days prior to study drug administration. Acceptable methods of contraception are:
  • intra-uterine contraceptive device (placed at least 4 weeks prior to study drug administration;
  • condom or diaphragm + spermicide;
  • hormonal contraceptives (starting at least 4 weeks prior to study drug administration).
  • History or known active pathological bleeding (e.g. peptic ulcer, intracranial hemorrhage).
  • Increased risks of bleeding (e.g. frequent nose bleeding, recent trauma, surgery or other pathological condition).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506713

Locations
Canada
Anapharm
Sainte-Foy (Quebec), Canada
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Denis Audet, MD Anapharm
  More Information

No publications provided

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01506713     History of Changes
Other Study ID Numbers: 60280
Study First Received: January 6, 2012
Last Updated: January 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Clopidogrel
Ticlopidine
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014