Skip to content

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.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522254-39-00
Acronym
1019/25
Enrollment
32
Registered
2025-09-10
Start date
2025-09-29
Completion date
2025-10-22
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioavailability study in healthy volunteers under fed conditions.

Interventions

None listed

Sponsors

Laboratorios Cinfa S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Countries

Czechia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026