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

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

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

Study Overview

• Status: Completed
• Conditions: Bioequivalence
• Intervention / Treatment: Drug: Clopid® 75 mg Tablet; Drug: Plavix® 75mg Tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75270
      • Center for Bioequivalence Studies and Clinical Research (CBSCR) ICCBS, University of Karachi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Center for Bioequivalence Studies and Clinical Research
• Collaborators: Ferozsons Laboratories Ltd.
• Investigators: Principal Investigator: Dr. Muhammad R Raza, PhD, Center for Bioequivalence Studies and clinical research

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2018
• Primary Completion (Actual): April 15, 2018
• Study Completion (Actual): April 20, 2018

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Bioequivalence; Clopidogrel; Platelet Aggregation Inhibitor
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: CB-024-CLO-2017/Protocol/1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The study related information can be obtained via proper request to the Co-PI/PI unless the confidentiality of the participants are not compromised

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No