In-vivo Bioequivalence Study of ASA 80 mg EC Tablet

In-vivo Bioequivalence Study of ASA 80 mg EC Tablet of The Test Drug (Sajjad Darou, Iran) in Compared with The Reference Drug (ASPIRIN® 80 mg. EC Tablet. BUYER, Germany) In Iranian Healthy Volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N128

Enrollment

Registered

2025-01-05

Start date

2025-01-30

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

In this study the , the disease is not investigated , bioequivalence of test and brand drug will be evaluated..

Interventions

Intervention 1: Intervention group: Single-dose of the test drug ASA 80 mg EC Tablet(Sajjad Darou, Iran). Intervention 2: Control group: Single-dose of the reference drug ASPIRIN® 80 mg. EC Tablet. BU

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 A history of liver & kidney disease Alcohol & Drug addiction Hypersensitivity to the drug Pregnancy

Design outcomes

Primary

Measure	Time frame
Plasma concentration of the drug. Timepoint: 0? 1? 2? 2.5? 3? 3.5? 4? 4.5? 5? 5.5? 6? 7? 8? 10? 12 h after drug adminstration 24. Method of measurement: HPLC-MS/MS.	—

Secondary

Measure	Time frame
Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma 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