Relative Bioavailability of Dabigatran Capsules, Pellets and Oral Solution in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Dabigatran etexilate

• Registration Number: NCT02044367
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate the relative bioavailability of dabigatran etexilate as pellets on food and of dabigatran etexilate as granules resolved in reconstitution solution, each with dabigatran etexilate as capsule following oral administration. To evaluate acceptability and palatability of Pellets sprinkled on food and Oral Liquid Formulation

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2015-04-10
• Results First Submitted QC: 2015-04-10
• Results First Posted: 2015-04-27
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-01
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test 2 (Treatment B)	Dabigatran etexilate	multiple dose of dabigatran
Test 1 (Treatment A)	Dabigatran etexilate	multiple dose of dabigatran
Reference	Dabigatran etexilate	multiple dose of dabigatran

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.	47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration	Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.
Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.	47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration	Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.	47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration	Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.
Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.	47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration	Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.
Acceptability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.	once on day 3 (48 hours after first dose)	Acceptability question: "Would you accept to take this medication for chronic use?" with 3 possible answers: Yes - No - I am not sure.
Palatability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.	once on day 3 (48 hours after first dose)	Palatability question: "How do you rank the taste?" with 5 possible answers: Very good - Good - Fair - Acceptable - Not acceptable.

Trial Locations

Locations (1)

1160.194.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany