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
ClinicalTrials.gov Identifier:
NCT01134965
First received: June 1, 2010
Last updated: April 7, 2011
Last verified: April 2011
  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:


Further study details as provided by Boehringer Ingelheim:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  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
Flibanserin
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Serotonin 5-HT1 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Serotonin 5-HT2 Receptor Antagonists

ClinicalTrials.gov processed this record on September 18, 2014