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

NCT05186129 | Completed Phase 1

• 1 other identifier: CB-024-CLO-2017/Protocol/1.0
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioequivalence

Keywords

Clopidogrel; Platelet Aggregation Inhibitor; Bioequivalence

Outcome Measures

Primary Outcomes (2)

• Cmax

  maximum plasma concentration

  0-36 hours post dose

• AUC

  Area under plasma concentration time curve

  0-36 hours post dose

Secondary Outcomes (3)

• Tmax

  0-36 hours post dose

• t 1/2

  0-36 hours post dose

• Incidence of Treatment-Emergent Adverse Event

  0-36 hours post dose

Study Arms (2)

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

EXPERIMENTAL

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

Drug: Clopid® 75 mg Tablet

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

ACTIVE COMPARATOR

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

Drug: Plavix® 75mg Tablet

Interventions

Clopid® 75 mg Tablet DRUG

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

Also known as: Clopidogrel

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

Plavix® 75mg Tablet DRUG

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

Also known as: Clopidogrel

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Healthy male Pakistani subjects
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center for Bioequivalence Studies and Clinical Research: lead
• Ferozsons Laboratories Ltd.: collaborator

Study Sites (1)

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

Karachi, Sindh, 75270, Pakistan

Location

MeSH Terms

Interventions

Tablets; Clopidogrel

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dr. Muhammad R Raza, PhD

  Center for Bioequivalence Studies and Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sub Investigator

Model Details: open label, randomized, single-dose, 2 way cross-over study

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 11, 2022
• Study Start: April 6, 2018
• Primary Completion: April 15, 2018
• Study Completion: April 20, 2018
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share

Locations

PA (1)