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

Population pharmacokinetic and pharmacodynamic modeling of Freefol-MCT® in healthy volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0001931

Enrollment

Registered

2016-05-25

Start date

2014-07-02

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug, Others(The rate of intravenous infusion of drug) : Sixty healthy volunteers aged more than 20 yr were given at a constant rate of Freefol-MCT®. Each volunteer was randomly assigned to an infusio

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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®.	—

Countries

Korea, Republic of

Contacts

Public ContactByung-Moon Choi

Asan Medical Center

rios76@hanmail.net

Outcome results