Study to Evaluate the Effects of Tramadol Hydrochloride on Cardiac Repolarization in Healthy Participants
Status:
Completed
Trial end date:
2015-08-27
Target enrollment:
Participant gender:
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).
Phase:
Phase 1
Details
Lead Sponsor:
Janssen Scientific Affairs, LLC
Collaborators:
Bausch Health Americas, Inc. Cipher Pharmaceuticals Inc. Valeant Pharmaceuticals International, Inc.
Treatments:
Fluoroquinolones Moxifloxacin Norgestimate, ethinyl estradiol drug combination Tramadol