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

Bioequivalence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05186129
• Other study ID #: CB-024-CLO-2017/Protocol/1.0
• Status: Completed
• Phase: Phase 1
• Start date: April 6, 2018
• Est. completion date: April 20, 2018

Study information

• Verified date: February 2022
• Source: Center for Bioequivalence Studies and Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 20, 2018
• Est. primary completion date: April 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bioequivalence

Intervention

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

Locations

Country	Name	City	State
Pakistan	Center for Bioequivalence Studies and Clinical Research (CBSCR) ICCBS, University of Karachi	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Center for Bioequivalence Studies and Clinical Research	Ferozsons Laboratories Ltd.

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	maximum plasma concentration	0-36 hours post dose
Primary	AUC	Area under plasma concentration time curve	0-36 hours post dose
Secondary	Tmax	time to reach maximum plasma concentration	0-36 hours post dose
Secondary	t 1/2	Terminal half-life	0-36 hours post dose
Secondary	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