Bio equivalence study of metformin 500 mg

Bio equivalence study of metformin 500 mg tablets manufactured by Sana Med pharmaceutical company on 24 healthy volunteers and comparing pharmacokinetics results with Glucophage tablets manufactured by MERCK.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200513047423N1

Enrollment

Registered

2020-06-24

Start date

2020-06-15

Completion date

Unknown

Last updated

2020-07-13

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

Conditions

Bioequivalence metformin 500 mg.

Interventions

Intervention 1: Intervention group1: One metformin 500 mg tablet manufactured by Sana Med company (Test drug) is administrated to each of 12 healthy volunteers of group 1 . Intervention 2: Interventi

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Healthy liver Healthy kidney observing BMI

Exclusion criteria

Exclusion criteria: Out of age ranges No smoker unhealthy liver and kidney pregnancy

Design outcomes

Primary

Measure	Time frame
Increasing plasma concentration after administration of metformin tablets till Tmax and then decreasing plasma concentration after Tmax. Timepoint: Initial blood sampling is performed before drug administration to obtain blank plasma chromatogram of each healthy volunteers. Hence the Tmax of metformin is between 1.5 and 3 hours, so it is needed to have 5 blood samplings before Tmax. This period of time is called absorption phase. In the elimination phase (after Tmax) blood sampling carry out each hours. As in some articles it is mentioned that Tmax of metformin is around 3 hours so the blood samples should be collected in 24 hours. Method of measurement: In this study, the variable is plasma concentration of metformin. High performance liquid chromatography is used to determine the concentration of metformin in plasma.	—

Measure

Time frame

Increasing plasma concentration after administration of metformin tablets till Tmax and then decreasing plasma concentration after Tmax. Timepoint: Initial blood sampling is performed before drug administration to obtain blank plasma chromatogram of each healthy volunteers. Hence the Tmax of metformin is between 1.5 and 3 hours, so it is needed to have 5 blood samplings before Tmax. This period of time is called absorption phase. In the elimination phase (after Tmax) blood sampling carry out each hours. As in some articles it is mentioned that Tmax of metformin is around 3 hours so the blood samples should be collected in 24 hours. Method of measurement: In this study, the variable is plasma concentration of metformin. High performance liquid chromatography is used to determine the concentration of metformin in plasma.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Amir mehdizadeh

Ofoqh pharmed labratory

A_mehdizadeh@yahoo.com+98 21 6673 8727

Outcome results

None listed

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