Conditions: Bioequivalence Fixed Dose Combination Tablets Healthy Male and Female Subjects
Keywords: dapagliflozin/metformin XR 5/500 mg dapagliflozin/metformin XR10/1000 mg bioequivalence fixed dose combination tablets pharmacokinetic type 2 Diabetes Mellitus (T2DM) safety
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 80
Healthy volunteers: yes

Brief summary:
This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions

Detailed description:
This is a Phase 1, 2-part, open-label, randomized, 4-period, 4-treatment, crossover study in healthy subjects (males and females of non-childbearing potential)

Arms:
arm 1: Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 5/500 mg dose arm 2: Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 5/500 mg dose arm 3: Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 5/500 mg dose arm 4: Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 5/500 mg dose arm 5: Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 10/1000 mg dose arm 6: Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 10/1000 mg dose arm 7: Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 10/1000 mg dose arm 8: Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 10/1000 mg dose

Interventions: intervention 1: dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon) intervention 2: dapagliflozin/metformin XR 5/500 mg reference drug (Humacao) intervention 3: dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon) intervention 4: dapagliflozin/metformin XR 10/1000 mg reference drug (Humacao)
Intervention descriptions: intervention 1: single fixed-combination dose tablets intervention 2: single fixed-dose combination tablets intervention 3: single fixed-dose combination tablets intervention 4: single fixed-dose combination tablets

Protocol document: