To determine the rate and extent of of absorption of racemic ketamine from sublingual wafer
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.
Study Type
OBSERVATIONAL
Enrollment
8
Pain and Anaesthesia Research Clinic (PARC), Royal Adelaide Hospital
Adelaide, South Australia, Australia
Bioavailability of a single 25 mg dose of sublingual (SL) ketamine
Bioavailability determined by evaluation and comparison of PK variables following SL and IV administration.
Time frame: 24 hours post-dose for two dosing periods, which were separated by 7 days.
General clinical tolerability and safety
Determined by using a range of objective and subjective parameters.
Time frame: 24 hours post-dose for two dosing periods, which were separated by 7 days.
Rate of disintegration
Measured the apparent rate of disintegration of a single 25 mg sublingual wafer formulation of ketamine.
Time frame: 5 minutes post-dose
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