A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Scientific Affairs, LLC
• Collaborators: Bausch Health Americas, Inc.; Cipher Pharmaceuticals Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Tramadol

Criteria

Inclusion Criteria:

• body mass index between 18 and 30 kg/m², inclusive

• body weight not less than 50 kg

• have a normal electroencephalogram under basic and stimulated conditions

• have a 12-lead ECG that is consistent with normal cardiac conduction and function

• have not used any tobacco products (eg, cigarettes, cigars, chewing tobacco, gum, or patch) for at least 6 months before first study drug administration

Exclusion Criteria:

• any personal or family history of epileptic seizures or convulsions

• have suffered from head trauma with loss of consciousness -have suffered from central nervous system infection

• have suffered from loss of consciousness of unknown origin

• drowning or sudden infant death syndrome in a first degree relative