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Bioequivalence study of Empagliflozin/linagliptin 10/5 mg tablets produced by Actoverco pharmaceutical company

Bioequivalence study of Empagliflozin/linagliptin 10/5 mg tablets produced by Actoverco pharmaceutical company with the reference drug GLYXAMBI 10/5 mg manufactured by Boehringer Ingelheim(Germany)

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240804062647N3
Enrollment
24
Registered
2024-10-29
Start date
2024-12-21
Completion date
Unknown
Last updated
2025-01-08

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 and drug concentration in plasma is determined..

Interventions

Intervention 1: First intervention group: Single dose, one oral Empagliflozin/linagliptin 10/5 mg tablet manufactured by Actoverco pharmaceutical company as test product. after washout period, the vol

Sponsors

?Actoverco Pharmaceutical Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General Health (Liver, Heart, and Kidney) Body Mass Index (18-30) 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

MeasureTime frame
Drug plasma concentration. Timepoint: 0,0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,10,12,24,48,72 h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass.

Secondary

MeasureTime 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 ContactMassoud Amanlou

Tehran University of Medical Sciences

amanlou@tums.ac.ir+98 21 6695 9067

Outcome results

None listed

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