Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects

Embolism, Atrial Fibrillation and Venous Thrombosis Clinical Trial

Official title:

Randomized, Non-blinded, Two-way Crossover Study to Establish the Bioequivalence Between a Rivaroxaban Tablet 10 mg and a Rivaroxaban Granule 10 mg in Japanese Healthy Adult Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02537405
• Other study ID #: 17018
• Status: Completed
• Phase: Phase 1
• First received: August 28, 2015
• Last updated: August 28, 2015
• Start date: February 2014
• Est. completion date: April 2014

Study information

• Verified date: August 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Japanese healthy male subjects

• 20 to 40 years of age

• 17.6 to 26.4 kg / m² of body mass index (BMI)

Exclusion Criteria:

• Subject with incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal

• Subject with a history of relevant diseases of vital organs, of the central nervous system or other organs, eg instable coronary heart disease, heart failure, liver failure, kidney failure, hypotension, or history of stroke or myocardial infarction

• Subject with known coagulation disorders (eg von Willebrand's disease, hemophilia)

• Subject with known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer)

• Subject with known sensitivity to common causes of bleeding (eg nasal)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Embolism, Atrial Fibrillation and Venous Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Rivaroxaban (BAY 59-7939)
Rivaroxaban granule 10mg for one day
• Rivaroxaban (Xarelto, BAY 59-7939)
Rivaroxaban tablet 10mg for one day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax (maximum observed drug concentration in measured matrix after single dose administration)		Multiple time point up to 3 day	No
Primary	AUC(0-tlast) (AUC from time 0 to the last data point > LLOQ (lower limit of quantitation))		Multiple time point up to 3 day	No
Secondary	Number of participants with adverse events as a measure of safety and tolerability		Up to 30 day	Yes

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here and search for websynopsis results based on ICH E3.