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NCT01464450 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetics Study of Oral Rivaroxaban in Healthy Participants

A Phase 1 study of Healthy Participants and Pharmacokinetics, sponsored by Janssen Scientific Affairs.

Completed
Registry status
Phase 1
Development phase
55
Enrollment target
1
Study location

NCT01464450 is a Phase 1 study of Healthy Participants and Pharmacokinetics that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 55 participants, below the 65-participant average among 119 other Healthy Participants trials with a reported enrollment target (15% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01464450, a Phase 1 study of Healthy Participants and Pharmacokinetics, has completed, sponsored by Janssen Scientific Affairs.

COMPLETED
Registry status
Phase 1
Development phase
55 participants
Enrollment target
1
Study location

Study Summary

The primary objective of this study is to learn about the relative bioavailability (the extent to which the drug becomes available to the body) and pharmacokinetics (blood levels) of rivaroxaban in healthy participants after receiving a 20 mg rivaroxaban tablet orally as a whole tablet, crushed and mixed in applesauce, and as a suspension through a Naso-gastric (NG) tube. The relative bioavailability of rivaroxaban may be different when given as a crushed tablet compared with an intact (whole) tablet and when given via an NG tube. The safety and tolerability of rivaroxaban will also be assessed.

Interventions

  • DRUG Rivaroxaban

Study Locations (1)

New Jersey

  • - Neptune City

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2011-10
Est. Completion 2011-12
Phase Phase 1

Sponsor

Janssen Scientific Affairs

37 total trials

What the Registry Record Tells You About NCT01464450

The ClinicalTrials.gov registry entry for NCT01464450 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 65-participant average among 119 other Healthy Participants trials with a reported enrollment target (15% lower). The listed sponsor is Janssen Scientific Affairs, which has 37 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Healthy Participants appearing as the primary indexed condition, and to 1 intervention - of which Rivaroxaban is the first listed.

NCT01464450 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.

Frequently Asked Questions

What is clinical trial NCT01464450 about?

NCT01464450 is a clinical study titled "Pharmacokinetics Study of Oral Rivaroxaban in Healthy Participants". The primary objective of this study is to learn about the relative bioavailability (the extent to which the drug becomes available to the body) and pharmacokinetics (blood levels) of rivaroxaban in healthy participants after receiving a 20 mg rivaroxaban tablet orally as a whole tablet, crushed and ...

What is the current status of trial NCT01464450?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2011-10. Estimated completion is 2011-12.

What conditions does trial NCT01464450 study?

This clinical trial studies the following conditions: Healthy Participants, Pharmacokinetics, Bioavailability.

What interventions are being tested in trial NCT01464450?

The interventions under investigation include: Rivaroxaban (DRUG).

Who is sponsoring clinical trial NCT01464450?

This trial is sponsored by Janssen Scientific Affairs, which has 37 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01464450 being conducted?

This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.