Bioequivalence Study of Clopidogrel Tablets 75 mg Under Fed Conditions

NCT01512485 | Completed Phase 1 DMC

• 1 other identifier: 60281
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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 fed condition.

Conditions

Healthy

Keywords

Bioequivalence; Clopidogrel; crossover

Outcome Measures

Primary Outcomes (1)

• Area Under Curve (AUC)

  predose, 0.250, 0.500, 0.750, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.0, 16.0, and 24.0 hours post-dose

Study Arms (2)

Clopidogrel

EXPERIMENTAL

Clopidogrel tablets 75 mg of Dr. Reddy's Laboratories Limited

Drug: Clopidogrel

Plavix

ACTIVE COMPARATOR

Clopidogrel Tablet 75 mg

Drug: Clopidogrel

Interventions

Clopidogrel DRUG

Clopidogrel Tablets 75 mg

Also known as: Plavix

Clopidogrel; Plavix

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Anapharm

Sainte-Foy (Quebec), Canada

Location

MeSH Terms

Interventions

Clopidogrel

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Denis Audet, MD

  Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: January 19, 2012
• Study Start: October 1, 2006
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: January 19, 2012

Record last verified: 2012-01

Locations

CA (1)