Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 30
Healthy volunteers: yes

Brief summary:
Main objective is to investigate mutual pharmacokinetic drug-drug interactions of digoxin, furosemide, metformin, and rosuvastatin when given all together as a cocktail

Detailed description:

Arms:
arm 1: 1 tablet (0.25 mg) digoxin as single dose arm 2: 0.1 mL (1 mg) furosemide oral solution as single dose arm 3: 0.1 mL (10 mg) metformin oral solution as single dose arm 4: 1 tablet (10 mg) rosuvastatin as single dose arm 5: 1 tablet (0.25 mg) digoxin, 0.1 mL (1 mg) furosemide oral solution, 0.1 mL (10 mg) metformin oral solution, and 1 tablet (10 mg) rosuvastatin, all together as a single dose ('cocktail')

Interventions: intervention 1: Digoxin intervention 2: Furosemide intervention 3: Metformin intervention 4: Rosuvastatin intervention 5: Digoxin intervention 6: Furosemide intervention 7: Metformin hydrochloride intervention 8: Rosuvastatin
Intervention descriptions: intervention 1: single dose intervention 2: single dose intervention 3: single dose intervention 4: single dose intervention 5: 0.25 mg digoxin as single dose (all 4 drugs given together as a cocktail at the same time point) intervention 6: 1 mg furosemide as single dose (all 4 drugs given together as a cocktail at the same time point) intervention 7: 10 mg metformin hydrochloride as single dose (all 4 drugs given together as a cocktail at the same time point) intervention 8: 10 mg rosuvastatin as single dose (all 4 drugs given together as a cocktail at the same time point)

Protocol document: