In-vivo Bioequivalence study of Mezasa granules with brand drugs (PENTASA Ferring Pharmaceuticals Co, Gremany)

In- Vivo Bioequivalence study of Mesalazine SR. granules 2 g Kooshan Pharmed Co. (Mezasa® 2g SR. granules) with brand drugs (PENTASA® 2g SR. granules (Ferring Pharmaceuticals Co, Gremany) in Iranian healthy volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N40

Enrollment

Registered

2021-09-19

Start date

2021-09-01

Completion date

Unknown

Last updated

2021-11-01

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: will receive one test granules tablet (Mezasa® 2g SR granules Kooshan Pharmed Co). Blood samples will be taken from the volunteers for 72 hours at the mentioned tim

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: General health Body mass index(18-28) Informed consent Age(18-60)

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
Determination of blood drug concentration. Timepoint: Sampling times in this study will be 0, 1, 2, 2:30, 3, 3:20, 3:40, 4, 4:20, 4: 40, 5, 6, 8, 10, 12, 24, 48, 72 hours After prescribing the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Shokri

Tabriz University of Medical Sciences

Shokri.j@gmail.com+98 41 3334 8489

Outcome results

None listed

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