Study of Sitagliptine/ Metformin table In-Vivo Bioequivalence in healthy volunteers

In- Vivo Bioequivalence study of Sitagliptine/ Metformin tablet with brand drugs (JANUMET 50/500mg (Merck Sharp & Dohme, Gremany) in Iranian healthy volunteers.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N12

Enrollment

Registered

2020-10-25

Start date

2020-11-10

Completion date

Unknown

Last updated

2020-11-09

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 Linagliptin tablets 5mg will evaluated..

Interventions

Intervention 1: Intervention group: Single dose of Sitagliptine/ Metformin tablet 50/500mg Razak Company as a test product. Intervention 2: Control group:Single dose of Sitagliptine/ Metformin tablet

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: General health (liver, heart, kidney) Body Mass Index (BMI) between 18-28 Informed consent Age between 18-60 Both male and female

Exclusion criteria

Exclusion criteria: Smoking Hypersensitivity to the drug Alcohol & Drug addiction Pregnancy

Design outcomes

Primary

Measure	Time frame
Determination of blood drug concentration. Timepoint: Sampling times in this study will be 0, 1, 2, 2:30, 3, 3:20, 3:40, 4, 4:20, 4: 40, 5, 6, 8, 10, 12, 24, 48, 72 hours. Method of measurement: Liquid Chromatography with tandem mass spectroscopy detector.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Shokri

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