|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01134965 |
|
Date of registration:
|
01/06/2010 |
|
Primary sponsor: |
|
|
Public title:
|
to Evaluate Effect of Multi Doses Flibans 100 mg Film-c Tablets on Single Dose PK of Digoxin 0.5 mg, Healthy Volunteers
|
|
Scientific title:
|
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 |
|
Date of first enrolment:
|
June 2010 |
|
Target sample size:
|
24 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01134965 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
Boehringer Ingelheim |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Boehringer Ingelheim Pharmaceuticals |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
healthy male and female subjects
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Healthy
|
|
Intervention(s)
|
|
Drug: Digoxin
|
|
Drug: Flibanserin plus Digoxin
|
|
Primary Outcome(s)
|
|
Area under the concentration-time curve of digoxin in plasma over the time interval 0 to infinity (AUC0-inf)
[Time Frame: 72 hours]
|
|
Maximum concentration of digoxin in plasma after single dose (Cmax)
[Time Frame: 72 hours]
|
|
Secondary Outcome(s)
|
|
Renal clearance of digoxin from time 0 to 24 hours after drug administration (CLR,0-24)
[Time Frame: 72 hours]
|
|
Secondary ID(s)
|
|
2010-018950-11
|
|
511.158
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|