Drug-drug Interaction Between Digoxin, Furosemide, Metformin, and Rosuvastatin
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02231931
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To investigate the mutual interaction potential of digoxin, furosemide, metformin, and rosuvastatin when given alone or together as a cocktail, and to investigate the effect of high doses of metformin or furosemide on pharmacokinetics of the other cocktail compounds
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description E (Test) 1 Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin Digoxin (1 tablet), Furosemide (0.5 mL oral solution), Metformin hydrochloride (1 film-coated tablet), Rosuvastatin (1 film-coated tablet), fasted G (Test 3) Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin Digoxin (1 tablet), Furosemide (2.0 mL oral solution), Metformin hydrochloride (1 film-coated tablet), Rosuvastatin (1 film-coated tablet), fasted F (Test 2) Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin Digoxin (1 tablet), Furosemide (0.5 mL oral solution), Metformin hydrochloride (2 film-coated tablets), Rosuvastatin (1 film-coated tablet), fasted A (Reference 1) Digoxin Digoxin 1 tablet as single dose, fasted B (Reference 2) Furosemide Furosemide oral solution, as single dose, fasted C (Reference 3) Metformin hydrochloride Metformin hydrochloride 1 film-coated tablet as single dose, fasted D (Reference 4) Rosuvastatin Rosuvastatin 1 film-coated tablet as single dose, fasted
- Primary Outcome Measures
Name Time Method Digoxin, Metformin, Rosuvastatin: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) up to 96 hours Furosemide: Cmax (maximum measured concentration of the analyte in plasma) up to 36 hours Digoxin, Metformin, Rosuvastatin: Cmax (maximum measured concentration of the analyte in plasma) up to 96 hours Furosemide: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) up to 36 hours
- Secondary Outcome Measures
Name Time Method Digoxin, Metformin, Rosuvastatin: AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) up to 96 hours Furosemide: AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) up to 36 hours
Trial Locations
- Locations (1)
352.2082.1 Boehringer Ingelheim Investigational Site
🇩🇪Biberach, Germany