Study of Freefol-MCT PKPD in Healthy Volunteers

The purpose of this study is to analysis PKPD of Freefol-MCT and to investigate relationship between the concentration of Freefol-MCT and the index which signaly analyzes those: EEG, EEG approximate entropy, systolic BP, saturation wave form and invasive BP wave form.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Other: Age: 20-40years; Other: Age: 41-64years; Other: Age: ≥65years

• Study Type: Observational
• Enrollment (Anticipated): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy Adults over 20years old

Description

Inclusion Criteria:

• Adults males/Females aged over 20years
• Health screening examination within 60 days of the start (Interview, vital signs , 12-lead ECG, blood tests, urinalysis) .
• The applicant who agreed in writing by told an explanation enough about the characteristics of the study drug, the purpose of the test and the details.

Exclusion Criteria:

• Subjects with clinically significant disease or history such as Liver, kidney, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous psychiatric, blood tumor system and cardiovascular. (In particular, bronchial asthma, severe hepatic, renal failure, severe blood disorders, severe myasthenia gravis, cardiac dysfunction, peptic ulcer, etc.)
• Who had acute disease or organ dysfunction within four weeks of the start of the test.
• Who had significant hematologic disorders or donate whole blood within two months of the start of the test.
• Significant neuropsychiatric or more.
• Continued drug abuse.
• Who has a history of drug and other hypersensitivity reactions.
• Positive at Type B / C hepatitis , syphilis tests (VDRL), if in AIDS antibody test
• Who took other clinical medicine within two months of the start of the test.
• Who smokes or drinks within two weeks after dosing.
• Who takes drugs regularly other than the mineral claim or vitamin. However, it depends on judgment of the researchers.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A; Gender: 10 Males, 10 Females	Other: Age: 20-40years
B; Gender: 10 Males, 10 Females	Other: Age: 41-64years
C; Gender: 10 Males, 10 Females	Other: Age: ≥65years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Non- compartment pharmacokinetic parameters	1200 minutes
Compartment pharmacokinetic parameters	1200 minutes
BIS	1200 minutes
SBP	1200 minutes
E0	1200 minutes
Emax	1200 minutes
Ce50	1200 minutes
ke0	1200 minutes

Collaborators and Investigators

• Sponsor: Daewon Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Primary Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: February 24, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimate): March 10, 2015

Study Record Updates

• Last Update Posted (Estimate): October 10, 2016
• Last Update Submitted That Met QC Criteria: October 7, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Freefol_PKPD_2013