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In-vivo Bioequivalence Study of Semaglutide 14 mg Tablets of The Test Drug (Semaglutide 14 mg Tabs., Dr Abidi Pharma, Iran)

In-vivo Bioequivalence Study of Semaglutide 14 mg Tablets of The Test Drug (Semaglutide 14 mg Tabs., Dr Abidi Pharma, Iran) in Compared with The Reference Drug (RYBELSUS® 14 mg Tabs, Novo Nordisck Inc, Denmark) In Iranian Healthy Volunteers

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200105046010N147
Enrollment
24
Registered
2025-08-04
Start date
2025-08-28
Completion date
Unknown
Last updated
2025-08-19

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..

Interventions

Intervention 1: Intervention group: Single-dose of Semaglutide 14 mg Tablets of The Test Drug (Semaglutide 14 mg Tabs., Dr.Abidi Pharma, , in the first period. Cross-over design with five weeks washin

Sponsors

?Dr.Abidi Pharma Co.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health (liver, heart, kidney) of volunteers Body mass index range (18-30) Informed consent form Age between18-55

Exclusion criteria

Exclusion criteria: Smoking Having a Alcohol & Drug addiction Having a hypersensitivity to the drug Pregnancy

Design outcomes

Primary

MeasureTime frame
The concentration of the drug in blood. Timepoint: 0, 0.033, 0.125, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72 hours after drug administration. Method of measurement: Liquid Chromatography with Mass-Mass Detector.

Secondary

MeasureTime frame
Time to reach maximum blood concentration. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration in blood is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Shokri

Tabriz University of Medical Sciences

shokri.j@gmail.com+98 41 3661 4125

Outcome results

None listed

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