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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Therapeutic Equivalency

Intervention: Rivaroxaban (Xarelto, BAY59-7939) (Drug); Rivaroxaban (Xarelto, BAY59-7939) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

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.

Clinical Details

Official title: Single-dose, Open-label, Randomized, 2-way Crossover Pivotal Bioequivalence Study of 2x5 mg Tablets Rivaroxaban Versus 1x10 mg Tablet Rivaroxaban Under Fasted Condition in Healthy Subjects

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

Primary outcome:

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity After Single Dose (AUC) Incl. Bioequivalence (BE) Evaluation

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

Maximum Observed Drug Concentration in Plasma After Single Dose Administration (Cmax) Incl. Bioequivalence (BE) Evaluation

Secondary outcome:

Area Under the Plasma Concentration Versus Time Curve Divided by Dose Per kg Body Weight (AUCnorm)

Maximum Observed Drug Concentration in Plasma After Single Dose Administration Divided by Dose Per kg Body Weight (Cmax, Norm)

Mean Residence Time (MRT)

Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)

Half-life Associated With the Terminal Slope (t½)

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Healthy male subjects

- 18 to 45 years of age

- Body mass index (BMI) between 18 and 30 kg/m2

Exclusion Criteria:

- Conspicuous findings (medical history, screening)

- History of relevant diseases (internal organs, central nervous system or other

organs)

- Medical disorder, condition or history of such that would impair the subject's

ability to participate or complete this study in the opinion of the investigator or the sponsor

- Febrile illness within 1 week before the start of the study

- History of severe allergies, non-allergic drug reactions, or multiple drug allergies

- Hypersensitivity to the investigational drug, the control agent and/or to inactive

constituents

- Known coagulation disorders, known disorders with increased bleeding risk, known

sensitivity to common causes of bleeding

Locations and Contacts

Mönchengladbach, Nordrhein-Westfalen 41061, Germany
Additional Information

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Starting date: August 2009
Last updated: April 2, 2015

Page last updated: August 23, 2015

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