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

NCT05125549 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-11-18

No results posted yet for this study

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

Interventions

DRUG

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

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

DRUG

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

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

Sponsors & Collaborators

  • Joint Stock Company "Farmak"

    lead INDUSTRY

Principal Investigators

  • Vlad Udovytskyi · Joint Stock Company "Farmak"

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-12
Primary Completion
2018-08-27
Completion
2018-08-27

Countries

  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05125549 on ClinicalTrials.gov