Phase 1 N=36 Randomized Treatment

Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor and Assessment of Ticagrelor Interaction Potential With Dabigatran

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT01595854 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2013

Primary outcome: Primary: Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞) — 281.05; 485.48; 410.46 ng*h/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: dabigatran etexilate (Drug); Ticagrelor (Drug)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: Boehringer Ingelheim
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞)	281.05; 485.48; 410.46	—
PRIMARY Total Dabigatran: Maximum Measured Concentration (Cmax)	31.47; 61.30; 49.11	—
SECONDARY Number of Participants With Drug Related Adverse Events	0; 0; 0; 0; 0; 1	—

Summary

Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new pharmacodynamic methods

Eligibility Criteria

Inclusion criteria

Healthy male subjects

Exclusion criteria

Any relevant deviation from healthy conditions

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01595854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.