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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
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: Flibanserin plus Digoxin
Drug: Digoxin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Drug Information available for: Digoxin
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: June 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Drug: Flibanserin plus Digoxin
Flibanserin 100 mg once daily for 7 days plus Digoxin 0.5 mg as single dose
Experimental: Digoxin
Digoxin 0.5 mg as single dose
 Drug: Digoxin
Digoxin 0.5 mg as single dose

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

healthy male and female subjects

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134965

Locations
Germany
511.158.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01134965     History of Changes
Other Study ID Numbers: 511.158, 2010-018950-11
Study First Received: June 1, 2010
Last Updated: April 7, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Additional relevant MeSH terms:
Digoxin
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013