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A Trial to Learn How a New Liquid Form of Rivaroxaban Behaves and How Safe it is Compared to the Current Tablet Form of Rivaroxaban in Healthy Male Participants

NCT04720092 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-01-22

No results posted yet for this study

Summary

Researchers were looking for another way to treat people with a blood clot in their veins. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it behaves.

In this trial, the researchers learned how a new liquid form of rivaroxaban behaved compared to the tablet form in a small number of healthy participants. They also wanted to find out how safe it was. The trial included about 30 white men who were between the ages of 18 and 55. The participants also had a body mass index (BMI) between 18 and 29.9 kilograms per square meter (kg/m\^2). BMI is a measurement that uses a person's height and weight to learn how much body fat they have.

All the participants in this trial took 10 milliliter of the new form of rivaroxaban (containing 1 milligram \[mg\] of rivaroxaban per milliliter). Later they also took 10 mg of the current tablet form of rivaroxaban. They took each form 1 time by mouth.

This trial was a "crossover" trial. In a crossover trial, all the participants take all of the treatments, but in a different order. In between the 2 treatments, there was a "washout period" of at least 7 days. This was done so that the first treatment could leave each participant's body before they took their next treatment.

While taking each treatment, the participants stayed at the trial site for 5 days. During this time, they did not eat food for at least 10 hours before and at least 4 hours after taking each treatment. After taking the last treatment, the participants had a final visit about 7 to 14 days later.

During the trial, the doctors took blood and urine samples. They also did physical examinations and checked the participants' heart health using an electrocardiogram (ECG). They asked the participants questions about how they were feeling and if they had any medical problems.

Conditions

  • Thromboembolic Disorders

Interventions

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Granules for oral suspension, 10 mg, oral, single dose

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Tablet, 10 mg, oral, single dose

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-05
Primary Completion
2017-08-28
Completion
2017-10-27

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04720092 on ClinicalTrials.gov