In-vivo Bioequivalence Test of Metformin ER tablets1000 mg Kooshan Pharmed with brand drug (Glucophage® 1000 mg ER Tablet ,Merck Sharp & Dohme, German)

In- Vivo Bioequivalence study of Metformin ER tablets1000 mg Kooshan Pharmed Co. (Gly-Once® 1000 mg ER Tablet) with brand drugs (Glucophage® 1000 mg ER Tablet ,Merck Sharp & Dohme, Germany ) in Iranian healthy volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N70

Enrollment

Registered

2022-10-20

Start date

2022-10-17

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 ( Metformin ER tablets1000 mg Kooshan Pharmed) will be received. Blood samples will be taken for 24 hours at the mentioned times after drug administr

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 dru

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 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