to Evaluate Effect of Multi Doses Flibans 100 mg Film-c Tablets on Single Dose PK of Digoxin 0.5 mg, Healthy Volunteers
- Registration Number
- NCT01134965
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The aim of this trial is to investigate the effect of multiple doses of flibanserin on the single dose pharmacokinetics of digoxin in healthy female and male volunteers. Digoxin is a narrow therapeutic index drug for which a large number of relevant drug-drug interactions are known. Flibanserin is now under evaluation in postmenopausal women which increases the likelihood that flibanserin and digoxin will be administered together in the clinical setting.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Digoxin plus Flibanserin Flibanserin plus Digoxin Flibanserin 100 mg tablets once daily for 7 days plus Digoxin 0.5 mg (2 tables of 0.25 mg) as single dose Digoxin Digoxin Digoxin 0.5 mg as single dose
- Primary Outcome Measures
Name Time Method Maximum concentration of digoxin in plasma after single dose (Cmax) 72 hours Area under the concentration-time curve of digoxin in plasma over the time interval 0 to infinity (AUC0-inf) 72 hours
- Secondary Outcome Measures
Name Time Method Renal clearance of digoxin from time 0 to 24 hours after drug administration (CLR,0-24) 72 hours
Trial Locations
- Locations (1)
511.158.1 Boehringer Ingelheim Investigational Site
🇩🇪Biberach, Germany