Bioequivalence of Two Different Capsule Types of Dabigatran

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Dabigatran etexilate

• Registration Number: NCT01290757
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of this Phase I trial is to demonstrate the bioequivalence of two capsules of dabigatran etexilate made from two different drug product batches.

The reference batch is dabigatran etexilate hard capsules 150 mg using the currently approved capsule shell (Qualicaps). The test batch is dabigatran etexilate 150 mg hard capsules using a new capsule shell (Capsugel). The test batch is the drug product intended for future commercial use.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-02
• Study First Submitted QC: 2011-02-04
• Study First Posted: 2011-02-07
• Primary Completion: 2011-04
• Results First Submitted: 2012-04-18
• Results First Submitted QC: 2012-05-29
• Results First Posted: 2012-06-29
• Status Verified: 2013-12
• Last Update Submitted: 2014-05-08
• Last Update Posted: 2014-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dabigatran etexilate 150 mg (T)	Dabigatran etexilate	Capsugel (T), oral administration
Dabigatran etexilate 150 mg (R)	Dabigatran etexilate	Qualicaps (R), oral administration

Primary Outcome Measures

Name	Time	Method
Area Under the Curve 0 to tz (AUC0-tz) of Total Dabigatran	60 hours	Area under the concentration-time curve of total dabigatran in plasma from time 0 to the time of the last quantifiable data point, adjusted for treatment, period and sequence (all fixed effects), and random subject effect.
Maximum Measured Concentration (Cmax) of Total Dabigatran in Plasma	60 hours	Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.

Secondary Outcome Measures

Name	Time	Method
AUC0-tz of Free Dabigatran.	60 hours	Area under the concentration-time curve of free dabigatran in plasma from time 0 to the time of the last quantifiable data point. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.
AUC0-∞ of Free Dabigatran.	60 hours	Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.
Area Under the Curve 0 to Infinity (AUC0-∞) of Total Dabigatran.	60 hours	Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.
Cmax of Free Dabigatran in Plasma.	60 hours	Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.

Trial Locations

Locations (1)

1160.117.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Mannheim, Germany