Bioequivalence study of empagliflozin 25 mg film-coated tablet in Thai healthy volunteers

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20230719003

Enrollment

Registered

2023-07-19

Start date

2023-12-06

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Healthy Thai Volunteers Healthy Thai Volunteers

Interventions

Empagliflozin 25 mg, Jardiance 25 mg, product of Boehringer Ingelheim Pharma GmbH &amp

Co.KG, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany, imported by Boehringer Ingelheim (Thai) Ltd., Bangkok, Thailand.,Empagliflozin 25 mg, Empazin 25 mg, product of MacroPhar Co., Ltd. Bang

Active Comparator Drug,Experimental Drug

Reference Product,Test Product

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Healthy Thai Volunteers

Exclusion criteria

Exclusion criteria: Subjects who are with a history/evidence of drug sensitivity or allergic reaction to empagliflozin, or any related drug. Subjects who are positive for COVID-19 test.

Design outcomes

Primary

Measure	Time frame
PK parameter (Fasting condition) before (predose) and at 0.33, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 24.0, 36.0, 48.0 and 72.0 hours after dosing. Phoenix WinNonlin soft ware, Version 8.3 or above.	—

Secondary

Measure	Time frame
AUC 0-t before (predose) and at 0.33, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 12.0, 24.0, 36.0, 48.0 and 72.0 hours after dosing. Phoenix WinNonlin soft ware, Version 8.3 or above.	—

Countries

Thailand

Contacts

Public ContactMs. Nantaporn Prompila

Faculty of Medicine, Chulalongkorn University

nantaporn.p@chula.ac.th0632355951

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026