EUCTR2017-000609-18-DEActive, not recruitingPhase 1
Single-dose, open-label, randomized, 2-way crossover bioequivalence study of 20 mg granules for oral suspension rivaroxaban versus 20 mg tablets rivaroxaban under fed condition in healthy subjects
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Bayer AG
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
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.
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