In vivo bioequivalence study of Clopidogrel 75 mg tablets of Afa-Shimi Pharma, Iran

In vivo bioequivalence study of Clopidogrel 75 mg tablets of Afa-Shimi Pharma, Iran with brand drugs (PLAVIX 75 mg tablets, Sanofi, UK) in Iranian healthy volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N135

Enrollment

Registered

2025-02-05

Start date

2025-05-22

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study is performed on healthy volunteers..

Interventions

Intervention 1: Intervention group: Single-dose of the test drug Clopidogrel 75 mg tablets of Afa-Shimi Pharma, Iran in the first period. Intervention 2: Control group: Single-dose of the The Referen

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health(liver, heart, kidney) Body mass index(18-30) Informed consent Age(18-55)

Exclusion criteria

Exclusion criteria: Smoking history of cardiovascular disease history of liver & kidney disease Alcohol & Drug addiction Hypersensitivity to the drug Pregnancy

Design outcomes

Primary

Measure	Time frame
The concentration of the drug in blood. Timepoint: 0? 0.33? 0.66? 1.0? 1.33? 1.66? 2? 4? 6? 8? 10? 12 ,24h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass.	—

Secondary

Measure	Time frame
Time to reach maximum blood concentration. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration in blood is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Shokri

Tabriz University of Medical Sciences

shokri.j@gmail.com+98 41 3661 4125

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026