Each tablet contains dapagliflozin propanediol equivalent to dapagliflozin 10 mg.,Each film-coated tablet contains 10 mg dapagliflozin as dapagliflozin propanediol.
Sponsors
International Bio Service Co., Ltd.
Conditions
Bioequivalence study in healthy Thai Volunteers
Dapagliflozin 10 mg Film-coated Tablets (Dapagliflozin 10 mg FCT) and Reference Product (FORXIGA (10 MG FILM - COATED TABLETS)) in Healthy Thai Volunteers under Fasting ConditionsBioequivalence study in healthy Thai male volunteers
Dapagliflozin 10 mg Film-coated Tablets (Dapagliflozin 10 mg FCT) and Reference Product (FORXIGA (10 MG FILM - COATED TABLETS)) in Healthy Thai Volunteers under Fasting Conditions
Phase 1
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Dapagliflozin 10 mg Film-coated Tablets (Dapagliflozin 10 mg FCT) and Reference Product (FORXIGA (10 MG FILM - COATED TABLETS)) in Healthy Thai Volunteers under Fasting Conditions
TCTR20250102004
Start: 2025-05-05Target: 42Updated: 2026-08-03
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Dapagliflozin 10 mg Film-coated Tablets and Reference Product (FORXIGATM) in Healthy Thai Volunteers under Fasting Conditions
Active, not recruitingTCTR20250626005
Start: 2025-10-06Target: 42Updated: 2026-08-03