NCT04511637 is a Phase 1 clinical trial of Rivaroxaban (BAY 59-7939, Xarelto) in ODT form in Clinical Pharmacology, sponsored by Bayer.

Who is sponsoring NCT04511637?

NCT04511637 is sponsored by Bayer.

What drugs are being tested in NCT04511637?

Interventions in NCT04511637: Rivaroxaban (BAY 59-7939, Xarelto) in ODT form, Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form.

What condition does NCT04511637 study?

NCT04511637 studies Clinical Pharmacology.

Is NCT04511637 still recruiting?

NCT04511637 is currently completed. Last updated 13 August 2020.

Last reviewed 2020-08-13 · How we verify

NCT04511637

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Compare the Effect of the Formulations (Orally Disintegrating Tablet and Film-coated Tablet) on the Bioequivalence of Drug Rivaroxaban (Xarelto) at Dose of 15 mg in Japanese Healthy Male Adult Subjects

Completed Phase 1 Last updated 13 August 2020

What this trial tests

Phase 1 trial testing Rivaroxaban (BAY 59-7939, Xarelto) in ODT form in Clinical Pharmacology in 80 participants. Completed in 12 April 2019.

Timeline

21 January 2019

Primary endpoint
7 March 2019

12 April 2019

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	80
Start date	21 January 2019
Primary completion	7 March 2019
Estimated completion	12 April 2019
Sites	3 locations across Japan

Drugs / interventions tested

Rivaroxaban (BAY 59-7939, Xarelto) in ODT form — full drug profile →
Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form — full drug profile →

Conditions studied

Clinical Pharmacology — all drugs for Clinical Pharmacology →

Sponsor

Bayer — full company profile →

Who can join

Adults 20 to 40, male only, with Clinical Pharmacology. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 15 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 15 mg ODT either with or without water and one oral dose of rivaroxaban 15 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Rivaroxaban (BAY 59-7939, Xarelto) in ODT form

Trials testing the same drug.

NCT04511611 — Study to Compare the Effect of the Formulations (Orally Disintegrating Tablet and Film-coated Tablet) on Bioequivalence · Phase 1 · completed

Other recruiting trials for Clinical Pharmacology

Currently open trials in the same condition.

NCT07374224 — A Study Evaluating the Effects of Itraconazole or Rifampin on the Pharmacokinetic Characteristics of Rocbrutinib Tablet · Phase 1 · recruiting

Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04511637 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 13 August 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04511637.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing