Vivo Bioequivalence study

In-vivo Bioequivalence Study of Metformin ER.1000 mg FC. Tablets of The Test Drug (VARIOMET® ER. 1000 mg Tab., Faran Pharmed, Iran) in Compared with The Reference Drug (Glucophage® ER. 1000 mg. Merck Serono, Germany) in Iranian Healthy Volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N121

Enrollment

Registered

2024-09-11

Start date

2024-11-10

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

In this study the bioequivalence of test and brand of VARIOMET® will be evaluated..

Interventions

Intervention 1: Control group: Single-dose of the reference drug (Glucophage® ER. 1000 mg Tab, Merck Serono Inc.) in the first period. Intervention 2: Intervention Group: Single-dose of the test drug

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
Plasma concentration of the drug. Timepoint: After blood sampling. Method of measurement: HPLC-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