check_circleStudy Completed
Therapeutic Equivalency
Bayer Identifier:
14588
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Bioequivalence study in healthy subjects, 2*5 mg tablets Rivaroxaban versus 1*10 mg tablet Rivaroxaban
Trial purpose
The drug investigated in this study is Rivaroxaban, a novel, once-daily, oral anticoagulant for the prevention (prophylaxis) of deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery.
The purpose of this study is to establish bioequivalence of 2 immediate-release tablet treatments with Rivaroxaban: 2*5 mg tablets and 1*10 mg tablet will be given to healthy volunteers under fasting conditions; they will be administered as single oral doses in 2 periods. Both periods will be separated by a 7-day washout phase. Thus, the bioequivalence represents the primary study objective. As a secondary objective, this treatment will be assessed in terms of safety and tolerability.
Bioequivalence will be evaluated and verified on the basis of pharmacokinetic data. Blood samples of the volunteers will be taken at specific points in time; these samples will be analyzed using various statistical methods to establish pharmacokinetic characteristics required to compare the 2 treatments. The planned treatments with Rivaroxaban will be considered bioequivalent if specific criteria defined in the study protocol are met.
The study will be conducted in one center in Germany. 28 subjects meeting the inclusion criteria will participate. They will be treated according to a single-dose, randomized, 2-way cross-over, non-placebo-controlled design.
The purpose of this study is to establish bioequivalence of 2 immediate-release tablet treatments with Rivaroxaban: 2*5 mg tablets and 1*10 mg tablet will be given to healthy volunteers under fasting conditions; they will be administered as single oral doses in 2 periods. Both periods will be separated by a 7-day washout phase. Thus, the bioequivalence represents the primary study objective. As a secondary objective, this treatment will be assessed in terms of safety and tolerability.
Bioequivalence will be evaluated and verified on the basis of pharmacokinetic data. Blood samples of the volunteers will be taken at specific points in time; these samples will be analyzed using various statistical methods to establish pharmacokinetic characteristics required to compare the 2 treatments. The planned treatments with Rivaroxaban will be considered bioequivalent if specific criteria defined in the study protocol are met.
The study will be conducted in one center in Germany. 28 subjects meeting the inclusion criteria will participate. They will be treated according to a single-dose, randomized, 2-way cross-over, non-placebo-controlled design.
Key Participants Requirements
Sex
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
28Trial Dates
August 2009 - September 2009Phase
Phase 1Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | CRS Clinical-Research-Services Mönchengladbach GmbH | Mönchengladbach, 41061, Germany |
Primary Outcome
- Area under the plasma concentration versus time curve from time zero to infinity after single dose (AUC) incl. bioequivalence (BE) evaluationdate_rangeTime Frame:0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administrationenhanced_encryptionNoSafety Issue:
- Area under the plasma concentration versus time curve from time zero to last quantifiable concentration [AUC (0-tn)] incl. bioequivalence (BE) evaluationdate_rangeTime Frame:0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administrationenhanced_encryptionNoSafety Issue:
- Maximum observed drug concentration in plasma after single dose administration (Cmax) incl. bioequivalence (BE) evaluationdate_rangeTime Frame:0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administrationenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Area under the plasma concentration versus time curve divided by dose per kg body weight (AUCnorm)date_rangeTime Frame:0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administrationenhanced_encryptionNoSafety Issue:
- Maximum observed drug concentration in plasma after single dose administration divided by dose per kg body weight (Cmax, norm)date_rangeTime Frame:0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administrationenhanced_encryptionNoSafety Issue:
- Mean residence time (MRT)date_rangeTime Frame:0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administrationenhanced_encryptionNoSafety Issue:
- Time to reach maximum drug concentration in plasma after single dose (tmax)date_rangeTime Frame:0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administrationenhanced_encryptionNoSafety Issue:
- Half-life associated with the terminal slope (t½)date_rangeTime Frame:0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administrationenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2