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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018950-11 | EudraCT Number | EudraCT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digoxin plus Flibanserin | Experimental | Flibanserin 100 mg tablets once daily for 7 days plus Digoxin 0.5 mg (2 tables of 0.25 mg) as single dose |
|
| Digoxin | Experimental | Digoxin 0.5 mg as single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flibanserin plus Digoxin | Drug | Flibanserin 100 mg once daily for 7 days plus Digoxin 0.5 mg as single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Renal clearance of digoxin from time 0 to 24 hours after drug administration (CLR,0-24) | 72 hours |
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Inclusion criteria:
healthy male and female subjects
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 511.158.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 14, 2012 | |
| Reset | Apr 10, 2012 | |
| Release | Apr 10, 2012 | |
| Reset | Apr 30, 2012 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 14, 2012 | Apr 10, 2012 | |||
| Apr 10, 2012 |
| ID | Term |
|---|---|
| C098107 | flibanserin |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| Digoxin | Drug | Digoxin 0.5 mg as single dose |
|
| Apr 30, 2012 |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |