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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Page 1 of 1 (1 locations)

1

Asan Medical Center

Seoul, South Korea, 138-736