| Trial ID: | L0095 |
| Source ID: | NCT03143166
|
| Associated Drug: |
Dabigatran Etexilate
|
| Title: |
Pradaxa Tablet Proton Pump Inhibitor (PPI) Bioavailability (BA) Study in Japan
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
Has Results
|
| Results: |
https://ClinicalTrials.gov/show/NCT03143166/results
|
| Conditions: |
Non-alcoholic Fatty Liver Disease
|
| Interventions: |
Drug: Dabigatran Etexilate|Drug: Rabeprazol sodium
|
| Outcome Measures: |
Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Total Dabigatran (AUC0-tz).|Maximum Concentration of Total Dabigatran in Plasma (Cmax).|Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Free Dabigatran (AUC0-tz).|Maximum Concentration of Free Dabigatran in Plasma (Cmax).|Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-???).|Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-???).
|
| Sponsor/Collaborators: |
Boehringer Ingelheim
|
| Gender: |
Male
|
| Age: |
20 Years to 40 Years ?? (Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
36
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
May 22, 2017
|
| Completion Date: |
August 2, 2017
|
| Results First Posted: |
January 16, 2019
|
| Last Update Posted: |
January 16, 2019
|
| Locations: |
Souseikai Hakata Clinic, Fukuoka, Fukuoka, Japan
|
| URL: |
https://ClinicalTrials.gov/show/NCT03143166
|
