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An open label, balanced, randomized, single dose, two treatment, two period, two sequence, crossover, bioequivalence study comparing Dapagliflozin tablets 10mg, manufactured by Sun Pharmaceutical Industries Limited, India with Forxiga (Dapagliflozin) film-coated tablets 10 mg, manufactured by AstraZeneca AB Gärtunavägen, SE-151 85 Södertälje Sweden, in healthy adult, human subjects under fasting condition

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506408-18-00
Acronym
DAPAG-02-23
Enrollment
48
Registered
2023-11-09
Start date
2023-11-21
Completion date
2023-12-21
Last updated
2023-11-09

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

Conditions

diabetes

Interventions

None listed

Sponsors

Sun Pharmaceutical Industries Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Countries

Romania

Outcome results

None listed

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