NCT01377831

Study of Ketamine Administered Intravenously and by Sublingual Wafer

An Open Label, Two Way Crossover Study to Evaluate the Bioavailability and Clinical Tolerability of a Novel Sublingual Wafer Formulation of Ketamine in Healthy Male Volunteers

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: iX Biopharma Ltd. · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To determine the rate and extent of of absorption of racemic ketamine from sublingual wafer

Detailed description

1. To determine the apparent rate of disintegration of the sublingual wafer 2. To determine the overall clinical tolerability of ketamine when administered as a single dose via the sublingual route. Tolerability will be assessed using a range of objective and subjective parameters as assessed using modified Likert and Bond and Lader scales.

Conditions

• Pain

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-06-21
• Last updated: 2015-03-10

Locations

1 site across 1 country: Australia