Population Pharmacokinetic and Pharmacodynamic Modeling of Freefol-MCT® in Healthy Volunteers

Not Applicable

Completed

Conditions: Not Applicable

Registration Number: KCT0001931

Lead Sponsor: Asan Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. Adults older than 20 years old.
2. Within 60 days from the trial, normal state from the tests of history taking, vital signs, 12-lead ECG, blood tests, urine test.
3. Volunteers who agreed with the informed consents.

Exclusion Criteria

1. Persons with cardiovascular, pulmonary, renal, endocrinal diseases, bleeding tendency, gastrointestinal disease, cerebral nervous system problems, psychological problems or history of meningitis.
2. Within 4 weeks from the trial, persons who had acute orgal dysfunction or acute diseases.
3. Within 2 months from the trial, persons who had significant hematological disease, or donated the whole blood.
4. Persons with significant neuropsychological diseases.
5. Drug abuse.
6. History of hypersensitivity of drugs.
7. HBV Ag(+), HCV Ag(+), VDRL(+), AIDS Ab(+).
8. Within 2 months from the trial, history of taking of other medication from other clinical trial.
9. History of smoking or drinking alcohol within 2 weeks from the trial.
10. Taking of vitamines or minerals regularly.
11. Pregnancy.
12. Except for that, researchers made a decision.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic analysis was done of Freefol-MCT®. With the non-compartmental analysis and compartmental analysis. The compartmental analysis was done through the mixed effect modeling. Using BIS as a surrogate measurement of a consciousness, sigmoid maximum effect model and the pharmacokinetic model were linked directly. Blood-brain equilibration rate constant(Ke0) and pharmacodynamic variables were estimated from the population analysis.

Secondary Outcome Measures

Name	Time	Method
Systolic blood pressure, index processed from the raw EEG, electrocardiography, invasive arterial pressure wave, waves from the pulse oximetry were compared with the concentrations of Freefol-MCT®.