Fasted Bioequivalence Study of Clopidogrel Film-coated Tablets, 75 mg in 48 Healthy, Adult Male and Female Subjects.

NCT05125549 | Completed Phase 1

• 1 other identifier: FK-CLP
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to compare bioequivalence of the Test Product Clopidogrel bisulfate, film-coated tablets, 75 mg (JSC Farmak, Ukraine) and Reference Product Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France) in healthy male and female volunteers under fasting conditions.

Conditions

Pharmacokinetics

Keywords

bioequivalence; pharmacokinetics; generic drugs; Clopidogrel; Film-coated Tablets

Outcome Measures

Primary Outcomes (2)

• Сmax

  maximum plasma concentration observed

  up to 36 hours post-administration

• AUC0-t

  area under the plasma concentration versus time curve calculated by the trapezoidal rule from sampling time zero to sampling time of the last measurable plasma concentration

  up to 36 hours post-administration

Secondary Outcomes (1)

• tmax

  up to 36 hours post-administration

Other Outcomes (3)

• λz

  up to 36 hours post-administration

• t1/2

  up to 36 hours post-administration

• AUC0-∞

  up to 36 hours post-administration

Study Arms (2)

Treatment A

EXPERIMENTAL

Сlopidogrel bisulfate film-coated tablets, 75 mg (JSC Farmak, Ukraine)

Drug: Сlopidogrel bisulfate film-coated tablets, 75 mg (JSC Farmak, Ukraine)

Treatment B

ACTIVE COMPARATOR

Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France)

Drug: Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France)

Interventions

Сlopidogrel bisulfate film-coated tablets, 75 mg (JSC Farmak, Ukraine) DRUG

One film-coated tablet was administrated orally with 240 ml of water after an overnight fast

Also known as: Trombonet

Treatment A

Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France) DRUG

One film-coated tablet was administrated orally with 240 ml of water after an overnight fast

Treatment B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and non-pregnant and no breast-feeding females1), ≥18 and ≤50 years of age (on the day of Informed Consent). Caucasian race.
• Subject had provided his/her written informed consent before the start of any screening procedures.
• Subject was available for the whole study and to follow all the requirements of the study protocol.
• Body Mass Index (BMI) 18.5 to 30.0 kg/m2, inclusive (on the day of screening).
• Subject without any acute or chronic diseases of the cardiovascular system, neuroendocrine system, kidney, liver, gastrointestinal tract, respiratory system.
• Subjects in good health, as determined by screening medical history, physical examination, vital signs assessments (pulse rate, systolic and diastolic blood pressure, and body temperature) and 12-lead electrocardiogram (ECG). Minor deviations outside the reference ranges were acceptable, if deemed not clinically significant by the Investigator
• Sitting blood pressure is within normal ranges: 100 -140 mm Hg for systolic PB, 55 -95 mm Hg. for diastolic blood pressure (BP) at screening;
• Acceptance of use of contraceptive measures during the whole study by both female and male subjects.
• Non-smoker
• Subject is available to comply with the general dietary restrictions throughout the study.

You may not qualify if:

• History of severe allergy or allergic reactions to the study Investigational Medicinal Product (IMP), its excipients or related drugs.
• Aggravated allergic history
• History of any clinically significant disease or disorder or surgical intervention which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
• A positive result of Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), and / or (human immunodeficiency virus) HIV or syphilis tests during screening procedure.
• A positive results of urine drug of abuse test (amphetamine, methamphetamine, morphine, marijuana, cocaine).
• Positive result of alcohol breath test
• Positive urine cotinine test
• The values of the standard parameters of the laboratory and instrumental examinations are outside the normal range and are clinically relevant or require additional examination and interpretation.
• Pregnancy (positive urine pregnancy test result in women)
• Lactation period (for women).
• Acute infectious diseases in less than 28 days before the first dosing.
• Use of any medication for a period of 14 days before the first dosing.
• Donation of blood within 30 days before the first dosing.
• Participation in any other clinical study during last 90 days.
• Other reasons when participation of a volunteer in the study is undesirable in the opinion of the Investigator.

Sponsors & Collaborators

• Joint Stock Company "Farmak": lead

Study Sites (1)

Clinical and Diagnostics Center of National University of Pharmacy (NUPh).

Kharkiv, Ukraine

Location

MeSH Terms

Interventions

Clopidogrel

Intervention Hierarchy (Ancestors)

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

Study Officials

• Vlad Udovytskyi

  Joint Stock Company "Farmak"

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 18, 2021
• Study Start: July 12, 2018
• Primary Completion: August 27, 2018
• Study Completion: August 27, 2018
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)