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to Evaluate Effect of Multi Doses Flibans 100 mg Film-c Tablets on Single Dose PK of Digoxin 0.5 mg, Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01134965
First received: June 1, 2010
Last updated: April 7, 2011
Last verified: April 2011
History of Changes

June 1, 2010
April 7, 2011
June 2010
July 2010   (final data collection date for primary outcome measure)
  • Maximum concentration of digoxin in plasma after single dose (Cmax) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve of digoxin in plasma over the time interval 0 to infinity (AUC0-inf) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
The possible influence of multiple flibanserin doses on single dose digoxin plasma concentrations will primarily be determined on the basis of the PK parameters AUC0-inf and Cmax of digoxin. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01134965 on ClinicalTrials.gov Archive Site
Renal clearance of digoxin from time 0 to 24 hours after drug administration (CLR,0-24) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
The possible influence of multiple flibanserin doses on single dose digoxin plasma concentrations will also be investigated on the basis of CLR,0-24 of digoxin as a secondary analysis. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: Flibanserin plus Digoxin
    Flibanserin 100 mg once daily for 7 days plus Digoxin 0.5 mg as single dose
  • Drug: Digoxin
    Digoxin 0.5 mg as single dose
  • Experimental: Digoxin plus Flibanserin
    Flibanserin 100 mg tablets once daily for 7 days plus Digoxin 0.5 mg (2 tables of 0.25 mg) as single dose
    Intervention: Drug: Flibanserin plus Digoxin
  • Experimental: Digoxin
    Digoxin 0.5 mg as single dose
    Intervention: Drug: Digoxin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
Not Provided
July 2010   (final data collection date for primary outcome measure)

Inclusion criteria:

healthy male and female subjects
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01134965
511.158, 2010-018950-11
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP