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

PK/PD study on S(+)-ketamine.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24166

Enrollment

Registered

2006-05-30

Start date

2007-02-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Healthy volunteers free of pain will be tested.

Interventions

Infusion of S(+)-ketamine or placebo. The are three infusion schemes: I. In four subjects there will be two 30-min infusions of S(+)-ketamine, separated by 30-min of no-infusion (end of infusion is a

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy volunteers 18+.

Exclusion criteria

Exclusion criteria: 1. Obesity (BMI > 30); 2. Presence of medical disease (heart-, lung-, liver-, kidney-, neurologic 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 and Lactation.

Design outcomes

Primary

Measure	Time frame
Analgesia and Plasma Cp of ketamine.	—

Secondary

Measure	Time frame
Bowdle scale parameters.	—

Contacts

Public ContactAlbert Dahan

Leiden University Medical Center (LUMC), Department of Anesthesiology, P.O. Box 9600

a.dahan@lumc.nl+31 (0)71 5262301

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)