drugset / Trial / NCT01947920
A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers
Phase 1
Completed
30 enrolled
Janssen Scientific Affairs, LLC
Bausch Health Americas, Inc. · collabCipher Pharmaceuticals Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine the safety and tolerability profile of tramadol hydrochloride (HCl) given as oral doses every 6 hours, within the range of dosages supported by currently available toxicology and clinical data (200 mg to 600 mg per day).
Timeline
- Start
- 2013-08
- Primary completion
- 2013-11
- Completion
- 2013-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tramadol | Other / unclassified | 50 mg | Oral |
| Subject | Tramadol | Other / unclassified | 100 mg | Oral |
| Subject | Tramadol | Other / unclassified | 150 mg | Oral |
Indications
No indication recorded.