Respiratory effects of tapentadol and oxycodone assessed by pharmacokinetic-pharmacodynamic and response surface modeling in healthy volunteers
- Conditions
- pijnpain
- Registration Number
- NL-OMON48377
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Healthy volunteers of either sex aged 18-38 years
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>(1) Changes in breath-to-breath minute ventilation as measured at<br /><br>iso-hypercapnia; (2) Pain relief as measured by application of noxious stimuli<br /><br>to the skin. </p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>