Clinical Pharmacology Clinical Trial
Official title:
Randomized, Non-blinded, Two-way Crossover Study to Assess Bioequivalence Between a Rivaroxaban 10 mg Orally Disintegrating Tablet Administered With Water or Without Water and a Rivaroxaban 10 mg Film-coated Tablet in Japanese Healthy Male Adult Subjects
| NCT number | NCT04511611 |
| Other study ID # | 20087 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | |
| Last updated | |
| Start date | January 24, 2019 |
| Est. completion date | May 13, 2019 |
| Verified date | August 2020 |
| Source | Bayer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Researchers in this study wanted to compare the effect of the formulation (orally
disintegrating tablet and film-coated tablet) on the bioequivalence of drug Rivaroxaban
(brand name: Xarelto) at dose of 10 mg in Japanese healthy male subjects aged 20 to 40 years.
Rivaroxaban is an approved drug to be used for the prevention of events/diseases caused by
blood clots. Currently, there are two formulations of Rivaroxaban available on the market in
Japan and they are film-coated tablets and fine granules. To further improve patients'
convenience, a new formulation, orally disintegrating tablet (ODT, a drug dosage form
designed to be dissolved on the tongue rather than swallowed whole) is under development. The
goal of this study was to compare the effect of this new formulation with film-coated tablets
when taken with or without water.
Participants in this study received one oral dose of rivaroxaban 10 mg ODT either with or
without water and one oral dose of rivaroxaban 10 mg film-tablet. There were at least 5 days
between the two doses. Observation for each participant lasted about 6 weeks in total. Blood
samples were collected from the participants to measure the blood level of the study drug.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | May 13, 2019 |
| Est. primary completion date | March 27, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 20 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - Japanese healthy male subjects, aged 20 to 40 years (inclusive), with body mass index 17.6 to 26.4 kg/m² 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 known hypersensitivity to the study drugs (active substances or excipients of the preparations) - Subject with known coagulation disorders (e.g. von Willebrand disease, hemophilia) - Subject with febrile illness within 1 week before the first study drug administration - Subject with suspicion of drug or alcohol abuse - Subject with intake of foods or beverages containing grapefruit, pomelo, Seville orange, and tangelo within 1 week before the first study drug administration - Subject with therapies (e.g. physiotherapy, acupuncture, etc.) within 1 month before starting study treatment - Subject with clinically relevant findings in the electrocardiogram (ECG) such as a second- or third-degree atrioventricular block, prolongation of the QRS complex over 120 msec or of the corrected QT (QTc) interval over 450 msec - Subject with systolic blood pressure below 90 or above 130 mmHg - Subject with diastolic blood pressure below 45 or above 85 mmHg - Subject with clinically relevant deviations of the screened laboratory parameters from reference ranges |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Fukuoka Mirai Hospital | Fukuoka | |
| Japan | Medical Co. LTA Nishikumamoto hospital | Kumamoto | |
| Japan | Sumida Hospital | Sumida-ku | Tokyo |
| Lead Sponsor | Collaborator |
|---|---|
| Bayer | Janssen Research & Development, LLC |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cmax for plasma rivaroxaban concentration | Maximum observed concentration | Up to 48 hours after study medication | |
| Primary | AUC(0-tlast) for plasma rivaroxaban concentration | Area under the concentration versus time curve from time 0 to the last data point > lower limit of quantitation | Up to 48 hours after study medication | |
| Secondary | Number of subjects with treatment-emergent adverse events | Up to 30 days after study medication |
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