Phase 1
Completed N=36
Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor and Assessment of Ticagrelor Interaction Potential With Dabigatran
Healthy
Source: ClinicalTrials.gov NCT01595854 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞) — 281.05; 485.48; 410.46 ng*h/mL
Summary
Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new pharmacodynamic methods
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 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
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. Informational only — not medical advice.