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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01306175 |
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Date of registration:
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28/02/2011 |
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Primary sponsor: |
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Public title:
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Drug Interaction Study of Digoxin and BI 10773
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Scientific title:
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Relative Bioavailability of a Single Oral Dose of Digoxin (0.5 mg) When Administered Alone or in Combination With Multiple Oral Doses of BI 10773 (25 mg qd) in Healthy Male and Female Volunteers (an Open-label, Randomised, Two-way Crossover Study) |
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Date of first enrolment:
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February 2011 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01306175 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Boehringer Ingelheim |
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Address:
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Telephone:
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Email:
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Affiliation:
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Boehringer Ingelheim Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion criteria:
-Healthy male and female subjects
Exclusion criteria:
-Any relevant deviation from healthy conditions
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: Digoxin
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Drug: Digoxin plus BI 10773
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Primary Outcome(s)
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AUC 0-inf of digoxin (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
[Time Frame: 96 hours]
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Cmax of digoxin (maximum measured concentration of the analyte in plasma)
[Time Frame: 96 hours]
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Secondary Outcome(s)
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Area under the concentration-time curve in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC 0-tz ) after single dose
[Time Frame: 96 hours]
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Secondary ID(s)
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1245.40
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2010-023170-40
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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