Healthy Volunteers (Intended Indication: Type 2 Diabetes Mellitus) Clinical Trial
Official title:
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
A Study to Assess the Bioequivalence of the fixed dose combination (FDC) of Dapagliflozin and Sitagliptin, and Dapagliflozin 10 mg and Sitagliptin 100 mg administered as individual tablets in Healthy Subject
This study will be a randomized, open-label, 2-period, 2-treatment, single-dose, crossover study in healthy subjects (males and females), performed at a single study center. The study will assess the bioequivalence between a dapagliflozin/sitagliptin FDC tablet (test formulation) and a free combination of dapagliflozin 10 mg + sitagliptin 100 mg co-administered as individual tablets (reference formulation) in fasted conditions to healthy subjects. The study will also assess the Pharmacokinetics (PK) and safety and tolerability of dapagliflozin 10 mg and sitagliptin 100 mg when co-administered as individual tablets and as an FDC tablet. The study will comprise: - A Screening Period of maximum 28 days. - Two Treatment Periods (Treatment A or B) - A final Safety Follow-up Visit 7 to 14 days after the last dosing with the Investigational medicinal product (IMP) (Treatment A or B). There will be a minimum washout period of 7 days and a maximum of 14 days between each treatment period. All subjects will receive a single dose of the following treatments after an overnight fast of 10 hours: - Treatment A: 1 × dapagliflozin/sitagliptin FDC tablet (test formulation). - Treatment B: 1 × dapagliflozin 10 mg tablet + 1 × sitagliptin 100 mg tablet co-administered as individual tablets (reference formulation). Subjects will be randomized to one of 2 treatment sequences: Treatment A followed by Treatment B or Treatment B followed by Treatment A. ;