MedTrace Logo

Study to Evaluate the Effects of Tramadol Hydrochloride on Cardiac Repolarization in Healthy Participants

NCT02307864 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2018-08-29

No results posted yet for this study

Summary

The purpose of this study is to assess the effects of multiple doses of an immediate release (IR) formulation of tramadol hydrochloride (HCl) at therapeutic and supratherapeutic levels in healthy adult participants on the electrocardiogram (ECG) QT interval corrected for heart rate (QTc).

Conditions

  • Healthy

Interventions

DRUG

Tramadol HCl

Tramadol HCl 50 mg immediate release (IR) tablet administered orally.

DRUG

Moxifloxacin 400 mg

Moxifloxacin 400 mg tablet administered orally.

DRUG

Tramadol HCl Placebo

Placebo matched to tramadol HCl IR tablet administered orally.

DRUG

Moxifloxacin Placebo

Placebo matched to Moxifloxacin 400 mg tablet administered orally.

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    collaborator INDUSTRY

  • Cipher Pharmaceuticals Inc.

    collaborator INDUSTRY

  • Janssen Scientific Affairs, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Scientific Affairs, LLC Clinical Trial · Janssen Scientific Affairs, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-12-04
Primary Completion
2015-08-22
Completion
2015-08-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT02307864 on ClinicalTrials.gov