to Evaluate Effect of Multi Doses Flibans 100 mg Film-c Tablets on Single Dose PK of Digoxin 0.5 mg, Healthy Volunteers
An Open Two-way Cross-over Study to Evaluate the Effect of Multiple Doses of Flibanserin 100 mg Film-coated Tablets Given Once Daily on the Single Dose Pharmacokinetics of Digoxin 0.5 mg in Healthy Male and Female Volunteers
2 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedFirst Posted
Study publicly available on registry
June 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedApril 8, 2011
April 1, 2011
1 month
June 1, 2010
April 7, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Renal clearance of digoxin from time 0 to 24 hours after drug administration (CLR,0-24)
72 hours
Study Arms (2)
Digoxin plus Flibanserin
EXPERIMENTALFlibanserin 100 mg tablets once daily for 7 days plus Digoxin 0.5 mg (2 tables of 0.25 mg) as single dose
Digoxin
EXPERIMENTALDigoxin 0.5 mg as single dose
Interventions
Flibanserin 100 mg once daily for 7 days plus Digoxin 0.5 mg as single dose
Eligibility Criteria
You may qualify if:
- healthy male and female subjects
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
511.158.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 1, 2010
First Posted
June 2, 2010
Study Start
June 1, 2010
Primary Completion
July 1, 2010
Last Updated
April 8, 2011
Record last verified: 2011-04