Healthy volunteers Characteristics of oxycodone and tapentadol.
Conditions
Interventions
Subjects will receive oral tapentadol on two separate occasions, once for assessment of the respiratory effects and once for assessment of the anti-nociceptive effects. Subjects will receive oral oxyc
Sponsors
Leiden University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: - Healthy according to medical history, physical examination, vital signs, lab values, and ECG; - Age 18-38 years; - Able to give informed consent; - Body mass index < 30 kg/m2. - Female subjects on contraceptives.
Exclusion criteria
Exclusion criteria: - Presence of health issues including presence or history of any psychiatric, medical or neurologic disorder that may interfere with the current study (eg. neuropathic pain conditions); - Presence or a history of illicit drug use or excessive alcohol consumption (>21 units per week), - Known allergies to study medication. - A positive drug screen on the day of screening or on any of the study days, - Participation in another trial in the 3 months before enrolment, - Use of medication on a regular basis (e.g. pain medication), - Inability to fast for at least 8 hours prior to study treatment administration, - Pregnancy or lactation, - Inability to communicate with the research team - Elective surgery during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Changes in breath-to-breath minute ventilation as measured at iso-hypercapnia; - Change in nociception using experimental pain models | — |
Secondary
| Measure | Time frame |
|---|---|
| The drug concentration, respiratory and pain end-points will be used for construction of the Utility Functions. | — |
Contacts
Public ContactM. Velzen, van
LUMC, Anesthesiology, P5 Albinusdreef 2
Outcome results
None listed