In-vivo Bioequivalence Test of Mesalasine 500 mg EC tablet Faran shimi Pharma with brand drug (Asacol® 400 mg ER. Tablets. ?Tillotts Pharma AG, Switzerland)

In- Vivo Bioequivalence study of Mesalasine 500 mg EC tablet Faran shimi Pharma with brand drugs (Asacol® 400 mg ER. Tablets. ?Tillotts Pharma AG, Switzerland) in Iranian healthy volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N63

Enrollment

Registered

2022-06-26

Start date

2022-06-26

Completion date

Unknown

Last updated

2022-08-29

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: One test tablet ( Mesalasine 500 mg EC tablet Faran shimi Pharma ) will be received. Blood samples will be taken for 24 hours at the mentioned times after drug administration and the c

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: General health Body mass index between18-28 Informed consent Being at the age of 18-60 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? 1? 2? 3?4? 6? 6.5? 7? 7.5? 8? 9? 10? 10.5? 11? 12 ? 24 ,48 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