Healthy volunteers
Conditions
Interventions
Trade Name: Oxynorm
Product Name: Oxynorm
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Søren Sindrup, Dept. of Neurology, University Hospital of Odense
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteer between 20 and 40 years. Healthy according to medical history and physical examination. Informed consent given. Phenotyped or genotyped as extensive or poor metabolizer of sparteine. Female: Does the volunteer use safe contraception (IUD, gestagen injectiones or oral contraception) or test negative in u-HCG. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any known allergy or intolerance to oxycodone. Regularly drug therapy or medication (except contraceptives). Alcohol or medicine abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective of the trial will be to determine if the analgesic effect of Oxycodone in human experimental pain models depends on its metabolism to oxymorphone;Secondary Objective: Secondary it will be determined if Single Nukleotid Polymorphisms in the MDR-1 gene and the my-opioidreceptor are of relevance of the analgesic effect of Oxycodone in the same human experimental pain models.;Primary end point(s): To evaluate if Capsule Oxycodone 20 mg. vs placebo provides significantly better analgesic effect undergoing the following human experimental pain models: Pain detection and tolerance to single sural nerve stimulation and pain summation threshold to repetitive stimulation (3Hz). Peak pain intensity and discomfort was rated during a cold pressor test. | — |
Countries
Denmark
Outcome results
None listed