Adults 20 to 35, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)Primary· 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.
Group
Value
95% CI
Dabigatran Etexilate Capsule: Ref
600
± 51.8
Dabigatran Etexilate Tablet: A1
714
± 42.1
Dabigatran Etexilate Tablet: B1
318
± 327
Dabigatran Etexilate Tablet: C1
354
± 96.6
Dabigatran Etexilate Tablet: D1
649
± 78.6
Dabigatran Etexilate Tablet: E1
661
± 54.8
Cmax (Maximum Concentration of Free Dabigatran)Primary· 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).
Group
Value
95% CI
Dabigatran Etexilate Capsule: Ref
73.5
± 60.0
Dabigatran Etexilate Tablet: A1
86.8
± 39.3
Dabigatran Etexilate Tablet: B1
42.3
± 213
Dabigatran Etexilate Tablet: C1
45.5
± 81.5
Dabigatran Etexilate Tablet: D1
79.6
± 73.5
Dabigatran Etexilate Tablet: E1
79.2
± 52.7
AUC0-infinity (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)Secondary· 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).
Group
Value
95% CI
Dabigatran Etexilate Capsule: Ref
623
± 49.0
Dabigatran Etexilate Tablet: A1
735
± 40.2
Dabigatran Etexilate Tablet: B1
544
± 71.9
Dabigatran Etexilate Tablet: C1
444
± 60.3
Dabigatran Etexilate Tablet: D1
725
± 53.0
Dabigatran Etexilate Tablet: E1
684
± 51.9
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)Secondary· 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.
Group
Value
95% CI
Dabigatran Etexilate Capsule: Ref
726
± 52.9
Dabigatran Etexilate Tablet: A1
838
± 41.1
Dabigatran Etexilate Tablet: B1
366
± 341
Dabigatran Etexilate Tablet: C1
412
± 97.1
Dabigatran Etexilate Tablet: D1
777
± 74.9
Dabigatran Etexilate Tablet: E1
778
± 53.6
Cmax (Maximum Plasma Concentration of Total Dabigatran)Secondary· 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).
Group
Value
95% CI
Dabigatran Etexilate Capsule: Ref
88.6
± 62.0
Dabigatran Etexilate Tablet: A1
102
± 39.0
Dabigatran Etexilate Tablet: B1
47.9
± 227
Dabigatran Etexilate Tablet: C1
52.2
± 83.6
Dabigatran Etexilate Tablet: D1
94.2
± 75.7
Dabigatran Etexilate Tablet: E1
91.9
± 54.1
AUC0-infinity (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)Secondary· 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).
Group
Value
95% CI
Dabigatran Etexilate Capsule: Ref
750
± 50.5
Dabigatran Etexilate Tablet: A1
863
± 39.1
Dabigatran Etexilate Tablet: B1
628
± 75.6
Dabigatran Etexilate Tablet: C1
515
± 60.1
Dabigatran Etexilate Tablet: D1
804
± 70.1
Dabigatran Etexilate Tablet: E1
800
± 51.9
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 6 November 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02710630.