drugset / Trial / NCT02307864
Study to Evaluate the Effects of Tramadol Hydrochloride on Cardiac Repolarization in Healthy Participants
Phase 1
Completed
68 enrolled
Janssen Scientific Affairs, LLC
Bausch Health Americas, Inc. · collabCipher Pharmaceuticals Inc. · collab
RandomizedCrossoverTriple-blindTreatment
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).
Timeline
- Start
- 2014-12-04
- Primary completion
- 2015-08-22
- Completion
- 2015-08-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Moxifloxacin | Small molecule | 400 mg | Oral |
| Subject | Tramadol | Other / unclassified | 400 mg | Oral |
| Subject | Tramadol | Other / unclassified | 600 mg | Oral |
Indications
No indication recorded.