🇺🇸 FDA
Pipeline program

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.

01-DAP-BIO-24

Phase 1 other active

Quick answer

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. for 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. is a Phase 1 program (other) at Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A. with 1 ClinicalTrials.gov record(s).

Program details

Company
Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.
Indication
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.
Phase
Phase 1
Modality
other
Status
active

Clinical trials