WHO ICTRP trial
A single-dose, open-label, randomized, two-period, two-sequence, crossover…
CTIS2024-520212-18-00 · EU Clinical Trials Information System · Not Recruiting
Key facts
| Trial ID | CTIS2024-520212-18-00 |
|---|---|
| Public title | 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. |
| Scientific title | - 01-DAP-BIO-24 |
| Primary sponsor | Tarchominskie Zaklady Farmaceutyczne Polfa S.A. |
| Registry | EU Clinical Trials Information System |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): Yes Therapeutic exploratory (Phase II): No Therapeutic confirmatory - (Phase III): No Therapeutic use - (Phase IV): No |
| Countries | Czechia |
| 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. MedDRA version: 21.1Level… |
| Registration date | Feb 21, 2025 |
| Target size | 36 |
| Registry page | euclinicaltrials.eu |
At a glance
- Yes Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: