Bioequivalence Study of Clopid® (Clopidogrel) 75 mg Tablet and Plavix® 75 mg Tablet After Oral Administration to Healthy Adult Subjects Under Fasting Condition

Study Overview
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Brief Summary
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To compare the rate and extent of absorption of Clopid® (Clopidogrel) 75 mg Tablet and Plavix® (clopidogrel) 75 mg tablet under fasting condition.

Detailed Description
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Single dose, Randomized, Open-label, 2-Way Crossover, Bioequivalence Study of Clopid® of Ferozsons Laboratories Limited and Plavix® of Sanofi Winthrop Industrie France for Sanofi Pakistan Following a 75 mg Dose In Healthy Subjects Under Fasting Condition.

Official Title
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To Determine the Bioequivalence of Clopid® (Clopidogrel) 75 mg Tablet Manufactured by Ferozsons Laboratories Ltd. Pakistan and Plavix® 75 mg Tablet Manufactured by Sanofi Winthrop Industrie France for Sanofi Pakistan After Oral Administration to Healthy Adult Male Subjects Under Fasting Condition

Conditions
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Bioequivalence

Intervention / Treatment
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* Drug: Clopid® 75 mg Tablet
* Drug: Plavix® 75mg Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects , age between 18 to 55 years old Body mass index (BMI) between 18.5-30.0 kg /m2. Subject is willing to participate and to Sign written informed consent form Subjects should have a blood pressure after resting for at least three minutes between 100-139 mmHg (systolic) and 60-89 mmHg (diastolic). Subjects should have a supine (ECG) heart rate between 60 and 100 beats/min after resting for at least 3 minutes. Ability to fast for 10 hours and consume standard meal. Subjects must be in good health as determined by medical history, physical exmination, ECG, vital signs, medical tests including biochemistry, urinalysis, serology and hematology in serum/urine. Exclusion Criteria: • History of smoking , alcoholism, and a positive test for drugs of abuse, heavy pan or gutka user as judged by teeth / mouth inspection. Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication. Subjects allergic to Clopidogrel and/or, subjects who received any investigational drug within four weeks prior to screening. Intake of Smokeless tobacco, Tea, Coffee or other xanthenes derivatives (e.g. chocolate, cocoa) and poppy seeds 48 hours prior to study Check- In and must not consume grape fruit or juice of grape fruit at least 14 days prior to study. Donation or loss of more than 450 mL of blood within 3 months prior to the screening. Ingestion of OTC drug, within 14 days of drug administration (e.g. aspirin, ibuprofen) History of intake of any prescribed medicine during a period of 30 days, prior to drug administration day of study. Other prescription medication such as Antidepressent (Bupripion), CYP2C19 inhibitors (cimetidine, esomeprazole, etravirine, felbamate, fluconazole, fluoxetine, fluvoxamine, ketoconazole, omeprazole, ticlopidine, voriconazole), Macrolide and related antibiotics (erythromycin, telithromycin), Proton pump inhibitors (esomeprazole, omeprazole), Rifamycins (rifampin) and Anti-Coagluant (Warfarin) should also not be taken before 14 days. Individuals who had undergone any major surgery within 3 months prior to the start of the study, unless deemed eligible by the Principal Investigator or whomever he/she may designate. Subject has a history of any illness that, in the opinion of investigator might confound the result of the study or post additional risk in administrating Clopidogrel to the subject. Subjects having any external wound. Inability to take oral medication. Subjects with clinically significant abnormalities in investigations (safety assessments) as determined by the Investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: open label, randomized, single-dose, 2 way cross-over study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clopid® 75 mg(Clopidogrel)Tablet of Ferozsons Laboratories Ltd. Pakistan<br>Single dose of Clopid® 75 mg Tablet administered under fasting condition | Drug: Clopid® 75 mg Tablet<br>* Single dose of Clopid® 75 mg Tablet (Clopidogrel) was administered after a 10-hour overnight fast.<br>* Other names: Clopidogrel;|
| Active Comparator: Plavix® 75mg Tablet of Sanofi Winthrop Industrie France for Sanofi Pakistan.<br>Single dose of Plavix® 75 mg Tablet administered under fasting condition | Drug: Plavix® 75mg Tablet<br>* Single dose of Plavix® 75 mg Tablet (Clopidogrel) was administered after a 10-hour overnight fast.<br>* Other names: Clopidogrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | maximum plasma concentration | 0-36 hours post dose | 
| AUC | Area under plasma concentration time curve | 0-36 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | time to reach maximum plasma concentration | 0-36 hours post dose | 
| t 1/2 | Terminal half-life | 0-36 hours post dose | 
| Incidence of Treatment-Emergent Adverse Event | safety and tolerability of Experimental drug Clopid® (Clopidogrel) 75 mg Tablet and Comparator drug Plavix® 75mg Tablet in Pakistani population | 0-36 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clopidogrel, Platelet Aggregation Inhibitor, Bioequivalence