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
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