Bioequivalence study of Empagliflozin/Linagliptin 25/5 mg

Bioequivalence study of Empagliflozin/Linagliptin 25/5 mg manufactured by Kharazmi Co.versus originator brand GLYXAMBI® 25/5 mg manufactured by ??Boehringer ????? Co in fasting condition in healthy volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N99

Enrollment

Registered

2024-02-27

Start date

2024-02-20

Completion date

Unknown

Last updated

2024-03-06

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

Conditions

None listed

Interventions

Intervention 1: Intervention group: single dose, one oral Empagliflozin/ Linagliptin 25/5 mg (GLYXAMBI® 25/5mg) manufactured by ??Boehringer ????? Co as a reference product. after the washout period,

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General Health (Liver, Heart, and Kidney) Body Mass Index (18-28) Informed consent Age (18-55 years old)

Exclusion criteria

Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Alcoholism and Narcoticism History of allergy to Empagliflozin/Linagliptin

Design outcomes

Primary

Measure	Time frame
Drug plasma concentration. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 and 72h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass.	—

Secondary

Measure	Time frame
Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma 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