A Randomized, 2-period, 2-treatment, Single-dose, Crossover Study to Assess the Bioequivalence of the fixed dose combination (FDC) of Dapagliflozin 10 mg and Sitagliptin 100 mg, and Dapagliflozin 10 mg and Sitagliptin 100 mg administered as individual tablets in Healthy Subjects
Healthy volunteers (Intended Indication: Type 2 Diabetes Mellitus)
Dapagliflozin/sitagliptin FDC, Sitagliptin, Dapagliflozin
18 Years - 55 Years
Endpoint Classification: -
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Verified 01 Oct 2023 by AstraZeneca
No locations available
|Experimental: Treatment A (Test Formulation): Dapagliflozin/Sitagliptin FDC tablet|
Subjects will receive single dose of dapagliflozin/sitagliptin fixed dose combination (FDC) (test formulation).
Drug: Dapagliflozin/sitagliptin FDC
Subjects will receive single dose of Dapagliflozin/sitagliptin FDC orally.
|Active Comparator: Treatment B (Reference Formulation): Dapagliflozin+Sitagliptin|
Subjects will receive single dose of dapagliflozin 10 mg tablet + sitagliptin 100 mg tablet co-administered as individual tablets (reference formulation).
Subjects will receive 100 mg single dose of Sitagliptin orally.
Other Name: JANUVIA™
Subjects will receive 10 mg single dose of Dapagliflozin orally.
Other Name: FORXIGA™