NCT00908726

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 (LCT) propofol (Diprivan®; AstraZeneca, London, United Kingdom), such as infection, fat embolism, hypertriglyceridemia and pancreatitis. Originally, AquafolTM was formulated with 8% polyethylene glycol 660 hydroxystearate (Solutol HS 15, BASF Company Ltd., Seoul, Korea) and 5% tetrahydrofurfuryl alcohol polyethylene glycol ether (Glycofurol, Roche, Basle, Switzerland). A phase 1 study to assess the safety and tolerability of polymeric vehicles of this formulation in healthy volunteers showed dose-limiting toxicity. Subsequently, it was reformulated with 10% purified poloxamer 188 (PP188) as a nonionic block copolymer surfactant and 0.7% polyethylene glycol 660 hydroxystearate as a nonionic surfactant. Alterations in propofol formulation may result in altered pharmacokinetic, pharmacodynamic characteristics. The aim of this study was to compare the pharmacokinetics and pharmacodynamics of propofol microemulsion and lipid emulsion, using noncompartmental analysis and population analysis with mixed effects modeling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2009

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

January 20, 2012

Status Verified

January 1, 2012

Enrollment Period

1 year

First QC Date

May 22, 2009

Last Update Submit

January 18, 2012

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • The aim of this study was to compare the pharmacokinetics and pharmacodynamics of microemulsion and lipid emulsion propofol.

    Between 5/2/2009 until 5/31/2010

Study Arms (2)

Microemulsion propofol

EXPERIMENTAL
Drug: propofol

Lipid emulsion propofol

ACTIVE COMPARATOR
Drug: propofol

Interventions

propofolDRUG

Each subject received both propofol formulations in a crossover fashion separated by a 7-day washout period, and the order of the drug administration was randomized. Subjects received both propofol formulations (Lipid emulsion propofol: Diprivan® and Microemulsion propofol: AquafolTM) during 60 min. The infusion rate was assigned according to a nonblinded, randomized design to 1.5, 3, 6, or 12 mg/kg/hr.

Also known as: Microemulsion propofol: AquafolTM, Lipid emulsion propofol: Diprivan®
Lipid emulsion propofolMicroemulsion propofol

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1 or 2 (healthy or mild systemic illness) healthy volunteers
  • age ≥ 19 yr

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (2)

  • Kim KM, Choi BM, Park SW, Lee SH, Christensen LV, Zhou J, Yoo BH, Shin HW, Bae KS, Kern SE, Kang SH, Noh GJ. Pharmacokinetics and pharmacodynamics of propofol microemulsion and lipid emulsion after an intravenous bolus and variable rate infusion. Anesthesiology. 2007 May;106(5):924-34. doi: 10.1097/01.anes.0000265151.78943.af.

    PMID: 17457123BACKGROUND

  • Lee EH, Lee SH, Park DY, Ki KH, Lee EK, Lee DH, Noh GJ. Physicochemical properties, pharmacokinetics, and pharmacodynamics of a reformulated microemulsion propofol in rats. Anesthesiology. 2008 Sep;109(3):436-47. doi: 10.1097/ALN.0b013e318182a486.

    PMID: 18719441BACKGROUND

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Gyu-Jeong Noh, M.D. & Ph.D.

    Professor & Chairperson, Department of Clinical Pharmacology and Therapeutics, Asan Medical Center

    STUDY CHAIR

  • Byung-Moon Choi, M.D.

    Staff Anesthesiologist, Department of Anesthesiology and Pain Medicine, National Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of department of anesthesiology and pain medicine, and Clinical pharamcology

Study Record Dates

First Submitted

May 22, 2009

First Posted

May 27, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2010

Study Completion

June 1, 2011

Last Updated

January 20, 2012

Record last verified: 2012-01

Locations

KR(1)