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Bioequivalence Study in Healthy Subjects, 2*5 mg Tablets Rivaroxaban Versus 1*10 mg Tablet Rivaroxaban

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01436526
First Posted: September 19, 2011
Last Update Posted: April 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Bayer
Results First Submitted: November 18, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition: Therapeutic Equivalency
Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All participants (part.) recruited by CRS Clinical-Research-Services Moenchengladbach GmbH, Hindenburgstrasse 304 - 306, 41061 Moenchengladbach, Germany. 28 part. were planned to be enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
37 participants screened; 9 participants were screening failures; 28 participants were included in the study. Safety analysis: 27 individuals were analyzed in the group with 2*5mg, 27 individuals were analyzed in the group with 1*10mg.

Reporting Groups
  Description
Rivaroxaban (Xarelto, BAY59-7939) First 2*5 mg, Then 1*10 mg Single oral dose of rivaroxaban administered under fasting conditions 2*5 mg tablet in first intervention period and 1*10 mg tablet in second intervention period (after washout period)
Rivaroxaban (Xarelto, BAY59-7939) First 1*10 mg, Then 2*5 mg Single oral dose of rivaroxaban administered under fasting conditions 1*10 mg tablet in first intervention period and 2*5 mg tablet in second intervention period (after washout period)

Participant Flow for 2 periods

Period 1:   Period 1
    Rivaroxaban (Xarelto, BAY59-7939) First 2*5 mg, Then 1*10 mg   Rivaroxaban (Xarelto, BAY59-7939) First 1*10 mg, Then 2*5 mg
STARTED   14   14 
Participants Received Treatment   14   14 
COMPLETED   14   14 
NOT COMPLETED   0   0 

Period 2:   Period 2
    Rivaroxaban (Xarelto, BAY59-7939) First 2*5 mg, Then 1*10 mg   Rivaroxaban (Xarelto, BAY59-7939) First 1*10 mg, Then 2*5 mg
STARTED   13 [1]   13 [1] 
Participants Received Treatment   13   13 
COMPLETED   13   13 
NOT COMPLETED   0   0 
[1] 1 participant withdrew his consent after completing the first period.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rivaroxaban (Xarelto, BAY59-7939) First 2*5 mg , Then 1*10 mg Single oral dose of rivaroxaban administered under fasting conditions 2*5 mg tablet in first intervention period and 1*10 mg tablet in second intervention period (after washout period)
Rivaroxaban (Xarelto, BAY59-7939) First 1*10 mg, Then 2*5 mg Single oral dose of rivaroxaban administered under fasting conditions 1*10 mg tablet in first intervention period and 2*5 mg tablet in second intervention period (after washout period)
Total Total of all reporting groups

Baseline Measures
   Rivaroxaban (Xarelto, BAY59-7939) First 2*5 mg , Then 1*10 mg   Rivaroxaban (Xarelto, BAY59-7939) First 1*10 mg, Then 2*5 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   14   28 
Age 
[Units: Years]
Mean (Standard Deviation)
 31.6  (5.8)   31.3  (10.5)   31.4  (8.3) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   14   14   28 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity After Single Dose (AUC) Incl. Bioequivalence (BE) Evaluation   [ Time 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 administration ]

2.  Primary:   Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tn)] Incl. Bioequivalence (BE) Evaluation   [ Time 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 administration ]

3.  Primary:   Maximum Observed Drug Concentration in Plasma After Single Dose Administration (Cmax) Incl. Bioequivalence (BE) Evaluation   [ Time 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 administration ]

4.  Secondary:   Area Under the Plasma Concentration Versus Time Curve Divided by Dose Per kg Body Weight (AUCnorm)   [ Time 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 administration ]

5.  Secondary:   Maximum Observed Drug Concentration in Plasma After Single Dose Administration Divided by Dose Per kg Body Weight (Cmax, Norm)   [ Time 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 administration ]

6.  Secondary:   Mean Residence Time (MRT)   [ Time 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 administration ]

7.  Secondary:   Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)   [ Time 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 administration ]

8.  Secondary:   Half-life Associated With the Terminal Slope (t½)   [ Time 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 administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com



Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01436526     History of Changes
Other Study ID Numbers: 14588
2009-013032-20 ( EudraCT Number )
First Submitted: September 16, 2011
First Posted: September 19, 2011
Results First Submitted: November 18, 2011
Results First Posted: December 22, 2011
Last Update Posted: April 22, 2015