Phase 1 N=48 Treatment

Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT01734772 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2014

Primary outcome: Primary: Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) — 551; 817; 689; 660 ng*h/mL — p=0.9456

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 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)	551; 817; 689; 660; 844	0.9456
PRIMARY Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss)	83.6; 136; 106; 97.6; 121	0.9841

Summary

To investigate the pharmacokinetic and pharmacodynamic interaction of dabigatran and ticagrelor under steady state conditions; to investigate the effect of staggered administration of ticagrelor loading dose on dabigatran exposure (in Part II)

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 (NCT01734772). 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.