Bioavailability Study of Five Tablet Formulations of Dabigatran Etexilate Compared to Commercial Capsule Formulation in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Dabigatran etexilate tablet B1; Drug: Dabigatran etexilate capsule; Drug: Dabigatran etexilate tablet A1; Drug: Dabigatran etexilate tablet C1; Drug: Dabigatran etexilate tablet E1; Drug: Dabigatran etexilate tablet D1

• Registration Number: NCT02710630
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this trial is to investigate the relative bioavailability of five different tablet formulations of Dabigatran Etexilate, Formulation A1, Formulation B1, Formulation C1, Formulation D1, and Formulation E1, compared to commercial capsule formulation of Dabigatran Etexilate.

The secondary objective is to evaluate and compare several pharmacokinetic parameters between the treatments.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-14
• Study First Posted: 2016-03-17
• Study Start: 2016-03-22
• Primary Completion: 2016-05-11
• Study Completion: 2016-06-10
• Results First Submitted: 2017-05-08
• Results First Submitted QC: 2017-05-08
• Results First Posted: 2017-09-29
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

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 tablet B1	Dabigatran etexilate tablet B1	-
Dabigatran etexilate capsule	Dabigatran etexilate capsule	-
Dabigatran etexilate tablet A1	Dabigatran etexilate tablet A1	-
Dabigatran etexilate tablet C1	Dabigatran etexilate tablet C1	-
Dabigatran etexilate tablet E1	Dabigatran etexilate tablet E1	-
Dabigatran etexilate tablet D1	Dabigatran etexilate tablet D1	-

Primary Outcome Measures

Name	Time	Method
Cmax (Maximum Concentration of Free Dabigatran)	1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.	This outcome measure presents maximum concentration of analyte in plasma (Cmax).
AUC0-tz (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)	1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.	This outcome measure presents area under the concentration-time curve of free Dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point.

Secondary Outcome Measures

Name	Time	Method
Cmax (Maximum Plasma Concentration of Total Dabigatran)	1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.	This outcome measure presents maximum concentration of analyte in plasma (Cmax).
AUC0-tz (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)	1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.	This outcome measure presents area under the concentration-time curve of total Dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point.
AUC0-infinity (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)	1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.	This outcome measure presents area under the concentration-time curve of free Dabigatran in plasma over the time interval from 0 extrapolated to infinity)(if applicable).
AUC0-infinity (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)	1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.	This outcome measure presents area under the concentration-time curve of total Dabigatran in plasma over the time interval from 0 extrapolated to infinity)(if applicable).

Trial Locations

Locations (1)

SOUSEIKAI Sumida Hospital; 🇯🇵 Tokyo, Sumida-ku, Japan