A single-dose, open-label, randomized, two-period, two-sequence, crossover pivotal bioequivalence study on Dapagliflozin 10 mg film-coated tablets (Polfa Tarchomin S.A., Poland) versus Froxiga 10 mg film-coated tablets (AstraZeneca AB, Sweden) in healthy volunteers under fasting conditions.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-520212-18-00

Acronym

01-DAP-BIO-24

Enrollment

Registered

2025-03-27

Start date

2025-04-03

Completion date

2025-06-04

Last updated

2025-03-27

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

Conditions

intended for treatment of for the treatment of (2): • insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. • symptomatic chronic heart failure. • chronic kidney disease.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Countries

Czechia

Outcome results