Study of Freefol-MCT PKPD in Healthy Volunteers

Healthy Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02384720
• Other study ID #: Freefol_PKPD_2013
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 24, 2015
• Last updated: October 7, 2016

Study information

• Verified date: October 2016
• Source: Daewon Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Age: 20-40years

• Age: 41-64years

• Age: =65years

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daewon Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non- compartment pharmacokinetic parameters		1200 minutes	No
Primary	Compartment pharmacokinetic parameters		1200 minutes	No
Primary	BIS		1200 minutes	No
Primary	SBP		1200 minutes	No
Primary	E0		1200 minutes	No
Primary	Emax		1200 minutes	No
Primary	Ce50		1200 minutes	No
Primary	ke0		1200 minutes	No