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

NCT ID: NCT05186129

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-06
• Study Completion Date: 2018-04-20

Brief Summary

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

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.

Conditions

Bioequivalence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Clopid® 75 mg(Clopidogrel)Tablet of Ferozsons Laboratories Ltd. Pakistan

Single dose of Clopid® 75 mg Tablet administered under fasting condition

Group Type: EXPERIMENTAL

Clopid® 75 mg Tablet

Intervention Type: DRUG

Single dose of Clopid® 75 mg Tablet (Clopidogrel) was administered after a 10-hour overnight fast.

Plavix® 75mg Tablet of Sanofi Winthrop Industrie France for Sanofi Pakistan.

Single dose of Plavix® 75 mg Tablet administered under fasting condition

Group Type: ACTIVE_COMPARATOR

Plavix® 75mg Tablet

Intervention Type: DRUG

Single dose of Plavix® 75 mg Tablet (Clopidogrel) was administered after a 10-hour overnight fast.

Interventions

Clopid® 75 mg Tablet

Single dose of Clopid® 75 mg Tablet (Clopidogrel) was administered after a 10-hour overnight fast.

Intervention Type: DRUG

Plavix® 75mg Tablet

Single dose of Plavix® 75 mg Tablet (Clopidogrel) was administered after a 10-hour overnight fast.

Intervention Type: DRUG

Other Intervention Names

Clopidogrel; Clopidogrel

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ferozsons Laboratories Ltd.

INDUSTRY

Sponsor Role: collaborator

Center for Bioequivalence Studies and Clinical Research

OTHER

Sponsor Role: lead

Responsible Party

Dr. Naghma Hashmi

Sub Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Muhammad R Raza, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Bioequivalence Studies and Clinical Research

Locations

Center for Bioequivalence Studies and Clinical Research (CBSCR) ICCBS, University of Karachi

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

CB-024-CLO-2017/Protocol/1.0

Identifier Type: -

Identifier Source: org_study_id