Pharmacokinetic-pharmacodynamic modeling of S(+)-ketamine in healthy volunteers - KET STUDY
- Conditions
- Healthy volunteers
- Registration Number
- EUCTR2006-002979-40-NL
- Lead Sponsor
- MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Healthy volunteers, 18+ years
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
Obesity (BMI > 30);
Presence of medical disease (heart-, lung-, liver-, kidney-, neurologic disease; diabetes m.; pyrosis; diaphragmatic hernia);
Presence of psychiatric disease;
History of chronic alcohol or drug use;
Allergy to study medications;
Possibility of pregnancy; and
Lactation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study the relationship with plasma concentrations of S+-ketamine and analgesia;Secondary Objective: ;Primary end point(s): 1)To obtain pharmacokinetic parameters of S(+)-ketamine;<br><br>2)To study the pharmacodynamic effects of intravenous S(+)-ketamine on experimental pain;<br><br>3)To study the pharmacodynamic effects of intravenous S(+)-ketamine using Bowdle scales.<br>
- Secondary Outcome Measures
Name Time Method