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