In-vivo Bioequivalence Test of Ibuprofen tablet 800 mg Mofid Pharma with brand drug (BRUFEN® ER. 800 mg Tab, Mylan, Germany)

In- Vivo Bioequivalence study of Ibuprofen tablet 800 mg Mofid Pharma (DRASTIFEN® ER. 800 mgTab, Mofid Pharma, Iran) with brand drugs (BRUFEN® ER. 800 mg Tab, Mylan, Germany) in Iranian healthy volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N67

Enrollment

Registered

2022-09-04

Start date

2022-09-04

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Bio equivalence test.

Interventions

Intervention 1: Intervention group: One test tablet (Ibuprofen tablet 800 mg Mofid Pharma) will be received. Blood samples will be taken for 48 hours at the mentioned times after drug administration a

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health Body mass index between18-28 Informed consent Being at the age of 18-55 years old

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Plasma drug concentration. Timepoint: Sampling times in this study will be 0? 0.5? 1? 1.5? 2? 2.5? 3? 3.5? 4? 4.5? 5? 6? 10 .8? 12 , 24 hours after prescribing the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDariush Omidfar

Simin Baspar Teyf Gostar Company

Dariush.omidfar@gmail.com+98 41 3384 2724

Outcome results

None listed

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