Single-dose, open-label, randomized, 2-way crossover bioequivalence study of 10 mg granules for oral suspension rivaroxaban versus 10 mg tablets rivaroxaban under fasted condition in healthy subjects

Bayer AG0 个研究点目标入组 30 人开始时间: 2017年4月19日最近更新: 2018年4月30日

适应症

试验速览

暂无简介。

•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

•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

发起方