Status:
COMPLETED
Population Pharmacokinetics/Pharmacodynamics (PK/PD) of Microemulsion Propofol in Healthy Volunteers
Lead Sponsor:
Asan Medical Center
Conditions:
Healthy
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
AquafolTM (Daewon Pharmaceutical Co., Ltd., Seoul, Korea) is a microemulsion propofol that has been developed for eliminating lipid solvent-related adverse events of long chain triglyceride emulsion (...
Detailed Description
The Subjects fasted for 6 h before study drug administration. An 18-gauge angiocatheter was placed in a vein of the antecubital area. A second angiocatheter was placed in the contralateral radial arte...
Eligibility Criteria
Inclusion
- ASA 1 or 2 (healthy or mild systemic illness) healthy volunteers
- age ≥ 19 yr
Exclusion
- ASA 3 or above
- out with age group above
- contraindications against the use of propofol
- abnormal laboratory finding with clinical significance
- evidence of pregnancy
- history of alcohol or drug abuse
- neurological or psychiatric disease
- unable or unwilling to give informed consent
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00908726
Start Date
May 1 2009
End Date
June 1 2011
Last Update
January 20 2012
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736