In-vivo Bioequivalence Test of MODACOLIT SR Granules with brand drug (Ferring Pharmaceuticals Co, Gremany)

In- Vivo Bioequivalence study of Mesalazine SR granules 2 g, Teb Mofid Nikan Pharmed Co. (MODACOLIT® 2 g SR Granules) with brand drugs (PENTASA® 2g SR. granules) Ferring Pharmaceuticals Co, Germany in Iranian healthy volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N50

Enrollment

Registered

2021-12-25

Start date

2021-12-12

Completion date

Unknown

Last updated

2022-01-11

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 (Mesalazine SR granules 2 g ? produced by Teb Mofid Nikan Pharma.) will be received. Blood samples will be taken for 72 hours at the mentioned times

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, 1, 2, 3, 4, 6, 7, 8, 9, 10, 10:30, 11, 12, 24, 36, 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