Phase 1
Completed N=48
Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor
Healthy
Source: ClinicalTrials.gov NCT01734772 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: 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
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)
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 |
Eligibility Criteria
Inclusion criteria
- Healthy male subjects.
Exclusion criteria
- Any relevant deviation from healthy conditions.
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. Informational only — not medical advice.