check_circleStudy Completed
embolism, atrial fibrillation and venous thrombosis
Bayer Identifier:
17018
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Bioequivalence study of Rivaroxaban in Japanese healthy adult male subjects
Trial purpose
The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 10mg and rivaroxaban granule formulation 10mg, and to assess the safety and tolerability of rivaroxaban 10mg in healthy adult male subjects.
Key Participants Requirements
Sex
MaleAge
20 - 40 YearsTrial summary
Enrollment Goal
40Trial Dates
February 2014 - April 2014Phase
Phase 1Could I Receive a placebo
NoProducts
N/AAccepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Medical Co. LTA Nishikumamoto hospital | Kumamoto, 861-4157, Japan |
Primary Outcome
- Cmax (maximum observed drug concentration in measured matrix after single dose administration)date_rangeTime Frame:Multiple time point up to 3 dayenhanced_encryptionNoSafety Issue:
- AUC(0-tlast) (AUC from time 0 to the last data point > LLOQ (lower limit of quantitation))date_rangeTime Frame:Multiple time point up to 3 dayenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of participants with adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:Up to 30 dayenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2