testen van de tolerantie van CO2 inhalatie Physiological effect of carbon dioxide
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age of 18 to 35 years (inclusive); 2. Body Mass Index (BMI) between 18 and 25 kg/m2 (inclusive) and body weight between 50 kg and 100 kg (inclusive); 3. Subject is able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff;
Exclusion criteria
Exclusion criteria: 1. 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); 2. A semi recumbent systolic blood pressure of >150 mmHg and/or diastolic blood pressure of > 90 mmHg at screening; 3. History of alcoholism or substance abuse within three years prior to screening; 4. Use of medication during the study period; 5. Subjects smoking > 10 cigarettes/day or equivalents 6. Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year; 7. Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject, including pulmonary disease such as a history of asthma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in EEG, heart rate, blood pressure, cardiac output, ECG, oxygen content in the brain, sedation, cognition, nausea. | — |
Secondary
| Measure | Time frame |
|---|---|
| - | — |
Countries
Netherlands
Outcome results
None listed