Bioequivalence study of rivaroxaban granules for oral suspension and rivaroxaban tablets

Phase 1

• Conditions: Prevention and treatment of thromboembolic disorders; MedDRA version: 19.1Level: LLTClassification code 10043640Term: Thrombosis venousSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-000609-18-DE
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-19
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Healthy white male subjects aged 18 to 55 years (inclusive) with a body mass index between 18 and 29.9 kg/m2 (inclusive)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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.

Known or suspected liver disorders and bile secretion

Known thyroid disorders (TSH levels outside the normal reference range at Screening

Personal or familial history of genetically muscular diseases.

Known hypersensitivity to the study drugs (active substances or excipients of the preparations)

Known severe allergies e.g. allergies to more than 3 allergens, allergies affecting the lower respiratory tract or significant non-allergic drug reactions

Known disorders with increased bleeding risk (e.g., periodontosis, hemorrhoids, acute gastritis, peptic ulcer).Known sensitivity to common causes of bleeding (e.g. nasal).

Clinically relevant findings in the ECG ( second- or t AV block, prolongation of the QRS complex over 120 msec or of the QTc-interval over 450 msec)

Presence or history of arrhythmic disturbances or known congenital QT prolongation

Systolic blood pressure below 100 or above 140 mmHg

Diastolic blood pressure below 50 or above 90 mmHg Heart rate below 50 or above 90 beats/ min

Heart rate below 50 or above 90 beats/ min

Known hypersensitivity to components of the American breakfast

Vegetarian or special diets preventing the subjects from eating the standard meals during the study, especially the high-fat high-calorie American breakfast or reluctance to ingest it.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to <br><br>- establish bioequivalence with respect to AUC, AUC(0-tlast) and Cmax of 20 mg granules for oral suspension versus 20mg tablets rivaroxaban when administered as single oral dose under fed conditions ;Secondary Objective: The secondary objectives of the study are to <br><br>- investigate the safety and tolerability of rivaroxaban in healthy male subjects by means of the assessment of frequency of treatment-emergent adverse events;Primary end point(s): AUC, AUC(0-tlast), Cmax of rivaroxaban;Timepoint(s) of evaluation of this end point: From pre-dose up to 72 h after drug administration

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Frequency of TEAEs (assessed during the treatment phase and follow up);Timepoint(s) of evaluation of this end point: From pre-dose until 7-14 days after administration days (follow-up visit)