Vivo Bioequivalence study

In-vivo Bioequivalence Study of Metformin ER.500 mg FC. Tablets of The Test Drug (VARIOMET® ER. 500 mg Tab., Faran Pharmed, Iran) in Compared with The Reference Drug (Glucophage® ER. 500 mg. Merck Serono, Germany) in Iranian Healthy Volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N122

Enrollment

Registered

2024-09-16

Start date

2024-11-18

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

This study is performed on healthy volunteers and drug concentration in plasma is determined..

Interventions

Intervention 1: Control group: Intervention group: Single-dose (Glucophage® ER. 500 mg Tab, Merck Serono Inc.) as reference product. Intervention 2: Intervention group: Intervention group: Single dose

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health(liver, heart, kidney) Body mass index(18-28) Informed consent Age(18-55)

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
Time to reach maximum plasma concentration. Timepoint: After blood sampling. Method of measurement: HPLC,LC-MS/MS or UPLC-MS/MS.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Nemati

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