Opioid geïnduceerde ademdepressie Respiratory depression and reduced breathing
Conditions
Interventions
Oral administration of tablet: tapentadol (100 en 150 mg), oxycodone (20mg) and
placebo
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy male and female subjects;Age of 18 to 45 years (inclusive);;Body Mass Index (BMI) between 18 and 35 kg/m2 (inclusive) and body weight between 50 kg and 100 kg (inclusive); Subject is able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff; Subject is willing to comply with study restrictions.
Exclusion criteria
Exclusion criteria: Clinically relevant abnormal history of physical and mental health, as determined by medical history taking and physical examinations obtained during the screening visit and/or prior to the administration of the initial dose of the study drug (as judged by the investigator);;A semi recumbent systolic blood pressure of >160 mmHg and/or diastolic blood pressure of > 95 mmHg at screening;;History of alcoholism or substance abuse within three years prior to screening;;Positive pregnancy test;;Positive drug screening or alcohol breath test;;Subjects using more than 21 units of alcohol per week;;Use of medication during the study period;;If sexually active, the subject is not using contraceptives, or surgically sterilized;;Subject has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food;;Participation in an investigational drug trial in the 2 months prior to administration of the initial dose of study drug or more than 5 times per year;;Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of respiratory depression defined as a decrease in the slope of the Ventilation-CO2 curve, a rightward shift of the Ventilation-CO2 curve and extrapolations at fixed et-CO2 (7 and 9 kPa), resting ventilation and resting end-tidal PCO2. | — |
Secondary
| Measure | Time frame |
|---|---|
| A comparison of the degree of anti-nociception defined as the change in pain pressure threshold. | — |
Countries
Netherlands
Outcome results
None listed