Bioequivalance study of Metformin 1000 mg Tablets

Bioequivalance study of Metformin 1000 mg Tablets manufactured by Sana Med pharmaceutical company on 24 healthy volunteers and comparing pharmacokinetics results with Reference Tablets

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200513047423N8

Enrollment

Registered

2022-04-13

Start date

2022-07-29

Completion date

Unknown

Last updated

2022-05-02

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

Conditions

Bioequivalance Metformin 1000 mg.

Interventions

Intervention 1: Intervention group: One Metformin 1000 mg tablet manufactured by Sana Med company (Test drug) is administrated to each of 12 healthy volunteer of group 1. Intervention 2: Intervention

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Healthy liver Healthy kidney Volunteers should not be too fat or too thin and their weight index should be in the appropriate range

Exclusion criteria

Exclusion criteria: Out of age ranges smoking pregnancy

Design outcomes

Primary

Measure	Time frame
Plasma concentration changing after administration of Metformin 1000 mg tablet.Plasma concentration of Metformin at Tmax reaches about 1800 ng/mL and its measurement range is from 25ng / mL to 3000ng / mL. Timepoint: Initial blood sampling is performed before drug administration to obtain blank plasma chromatogram of each volunteers. Hence the Tmax of Metformin is between 1.5 and 3 hours, so it is needed to have 5 blood sampling before Tmax. This period of time is called absorption phase. In the elimination phase (after Tmax) blood sampling carry out each hours. Sampling is done in 10 and 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

Plasma concentration changing after administration of Metformin 1000 mg tablet.Plasma concentration of Metformin at Tmax reaches about 1800 ng/mL and its measurement range is from 25ng / mL to 3000ng / mL. Timepoint: Initial blood sampling is performed before drug administration to obtain blank plasma chromatogram of each volunteers. Hence the Tmax of Metformin is between 1.5 and 3 hours, so it is needed to have 5 blood sampling before Tmax. This period of time is called absorption phase. In the elimination phase (after Tmax) blood sampling carry out each hours. Sampling is done in 10 and 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

Ofoghfarmed.lab@gmail.com+98 21 6673 8727

Outcome results

None listed

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