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Pharmacokinetic-pharmacodynamic modeling of S(+)-KETamine in healthy volunteers

Pharmacokinetic-pharmacodynamic modeling of S(+)-KETamine in healthy volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN20522161
Enrollment
24
Registered
2007-02-26
Start date
2007-02-01
Completion date
Unknown
Last updated
2019-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ketamine, analgesic Signs and Symptoms Analgesic

Interventions

Infusion of S(+)-ketamine or placebo. There are three infusion schemes: 1. In four subjects there will be two 30-minute infusions of S(+)-ketamine, separated by 30 min

Sponsors

Leiden University Medical Centre (LUMC) (The Netherlands)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy volunteers 18+

Exclusion criteria

Exclusion criteria: 1. Obesity (Body Mass Index [BMI] more than 30) 2. Presence of medical disease (heart-, lung-, liver-, kidney-, neurological disease; diabetes m.; pyrosis; diaphragmatic hernia) 3. Presence of psychiatric disease 4. History of chronic alcohol or drug use 5. Allergy to study medications 6. Possibility of pregnancy 7. Lactation

Design outcomes

Primary

MeasureTime frame
Analgesia and plasma concentration of ketamine.

Secondary

MeasureTime frame
Bowdle scale parameters.

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026