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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
150 mg Capsugel (T)
150 mg Qualicaps (R)
1160.117.1 Boehringer Ingelheim Investigational Site
Mannheim, Germany
Area Under the Curve 0 to tz (AUC0-tz) of Total Dabigatran
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.
Time frame: 60 hours
Maximum Measured Concentration (Cmax) of Total Dabigatran in Plasma
Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.
Time frame: 60 hours
Area Under the Curve 0 to Infinity (AUC0-∞) of Total Dabigatran.
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.
Time frame: 60 hours
AUC0-tz of Free Dabigatran.
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.
Time frame: 60 hours
Cmax of Free Dabigatran in Plasma.
Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.
Time frame: 60 hours
AUC0-∞ of Free Dabigatran.
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.
Time frame: 60 hours
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