Trial Outcomes & Findings for Bioequivalence of Tablet Formulation of Dabigatran Etexilate Compared to Commercial Capsule Formulation Following Oral Administration in Healthy Male Subjects (NCT NCT03070171)

Last Updated: 2019-01-09

Results Overview

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 (AUC0-tz). Geometric Mean (gMean) is actually Adjusted gMean \& Geometric Coefficient of Variation (gCV) is actually Intra individual gCV (%gCV). PK exclusion criteria: 1) The subject experienced emesis at or before 2 times median Time from (last) dosing to the maximum measured concentration of the analyte in plasma (tmax). Median tmax was to be taken either from the median tmax for reference product or test product, depending on whether the subject had experienced emesis after taken the test or reference product. Median tmax was to be determined excluding the subjects experiencing emesis. 2) Time deviations 3) Use of restricted medications 4) A pre-dose concentration was \>5% of the Cmax value of that subject.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

160 participants

Primary outcome timeframe

1:00h before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.

Results posted on

2019-01-09

Participant Flow

Randomised, single-dose, open-label, replicate design in a two-treatments, four-period, two-sequence crossover design (T:Dabigatran etexilate tablet formulation 110 mg and R: Dabigatran etexilate capsule formulation 110 mg)

All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated.

Participant milestones

Participant milestones
Measure	T-R-R-T Subjects were treated with single oral dose, started in period 1 with 110 milligram (mg) Dabigatran etexilate tablet with 200 milliliter (mL) of water after an overnight fast of at least 10 hour (h), followed in period 2 and period 3 by 110 mg Dabigatran etexilate capsule with 200 mL of water after an overnight fast of at least 10 h, and in period 4 by 110 mg Dabigatran etexilate tablet with 200 mL of water after an overnight fast of at least 10 h. Treatment periods were separated by a wash-out phase of at least 4 days.	R-T-T-R Subjects were treated with single oral dose, started in period 1 with 110 mg Dabigatran etexilate capsule with 200 mL of water after an overnight fast of at least 10 h, followed in period 2 and period 3 by 110 mg Dabigatran etexilate tablet with 200 mL of water after an overnight fast of at least 10 h, and in period 4 by 110 mg Dabigatran etexilate capsule with 200 mL of water after an overnight fast of at least 10 h. Treatment periods were separated by a wash-out phase of at least 4 days.
Treatment Period 1 + Washout STARTED	80	80
Treatment Period 1 + Washout COMPLETED	80	80
Treatment Period 1 + Washout NOT COMPLETED	0	0
Treatment Period 2 + Washout STARTED	80	80
Treatment Period 2 + Washout COMPLETED	80	79
Treatment Period 2 + Washout NOT COMPLETED	0	1
Treatment Period 3 + Washout STARTED	80	79
Treatment Period 3 + Washout COMPLETED	80	79
Treatment Period 3 + Washout NOT COMPLETED	0	0
Treatment Period 4 + Washout STARTED	80	79
Treatment Period 4 + Washout COMPLETED	80	78
Treatment Period 4 + Washout NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	T-R-R-T Subjects were treated with single oral dose, started in period 1 with 110 milligram (mg) Dabigatran etexilate tablet with 200 milliliter (mL) of water after an overnight fast of at least 10 hour (h), followed in period 2 and period 3 by 110 mg Dabigatran etexilate capsule with 200 mL of water after an overnight fast of at least 10 h, and in period 4 by 110 mg Dabigatran etexilate tablet with 200 mL of water after an overnight fast of at least 10 h. Treatment periods were separated by a wash-out phase of at least 4 days.	R-T-T-R Subjects were treated with single oral dose, started in period 1 with 110 mg Dabigatran etexilate capsule with 200 mL of water after an overnight fast of at least 10 h, followed in period 2 and period 3 by 110 mg Dabigatran etexilate tablet with 200 mL of water after an overnight fast of at least 10 h, and in period 4 by 110 mg Dabigatran etexilate capsule with 200 mL of water after an overnight fast of at least 10 h. Treatment periods were separated by a wash-out phase of at least 4 days.
Treatment Period 2 + Washout Other Adverse Event	0	1
Treatment Period 4 + Washout Withdrawal by Subject	0	1