🇺🇸 FDA
Pipeline program

Single dose, open-label, laboratory blinded, randomized, 2-treatment, 2-period, 2-sequence, crossover, pivotal study to assess the comparative bioavailability of Test Product Dapagliflozin/metformin hydrochloride 5 mg/1000 mg film-coated tablets to Reference Product Xigduo 5 mg/1000 mg film-coated tablets in healthy adult male and female subjects under fed conditions.

1019/25

Phase 1 other active

Quick answer

Single dose, open-label, laboratory blinded, randomized, 2-treatment, 2-period, 2-sequence, crossover, pivotal study to assess the comparative bioavailability of Test Product Dapagliflozin/metformin hydrochloride 5 mg/1000 mg film-coated tablets to Reference Product Xigduo 5 mg/1000 mg film-coated tablets in healthy adult male and female subjects under fed conditions. for Bioavailability study in healthy volunteers under fed conditions. is a Phase 1 program (other) at Laboratorios Tillomed Spain S.L.U with 1 ClinicalTrials.gov record(s).

Program details

Company
Laboratorios Tillomed Spain S.L.U
Indication
Bioavailability study in healthy volunteers under fed conditions.
Phase
Phase 1
Modality
other
Status
active

Clinical trials