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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
To determine the rate and extent of of absorption of racemic ketamine from sublingual wafer
Details
| Lead sponsor | iX Biopharma Ltd. |
|---|---|
| Status | COMPLETED |
| Enrolment | 8 |
| Start date | 2011-06 |
| Completion | 2011-06 |
Conditions
- Pain
Primary outcomes
- Bioavailability of a single 25 mg dose of sublingual (SL) ketamine — 24 hours post-dose for two dosing periods, which were separated by 7 days.
Bioavailability determined by evaluation and comparison of PK variables following SL and IV administration.
Countries
Australia