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

Pharmacokinetic assessments of of Sitagliptine/ Metformin 50/500 tablet (??Dicemia) Kooshan Pharmed Co with brand drugs (JANUMET 50/500mg (Merck Sharp & Dohme, Gremany) in Iranian healthy volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N20

Enrollment

Registered

2021-01-13

Start date

2020-12-21

Completion date

Unknown

Last updated

2021-02-22

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 Sitagliptine/ Metformin tablets 50/500mg will evaluated..

Interventions

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

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