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Therapeutic Equivalence (TE) Study of Propofol 2% MCT Fresenius (MCT=Medium-Chain Triglycerides) Compared With Diprivan® in Patients Undergoing Elective Surgery

NCT01856998 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2014-02-21

No results posted yet for this study

Summary

The purpose of this study is to evaluate the therapeutic equivalence, based on pharmacodynamic parameters of Propofol 2% (20 mg/mL) MCT Fresenius and Diprivan® 20 mg/mL (AstraZeneca), administered by target controlled infusion (TCI).

Conditions

  • General Anesthesia
  • Elective Surgery

Interventions

DRUG

Propofol

DRUG

Diprivan

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Fresenius Kabi

    lead INDUSTRY

Principal Investigators

  • Francois Sztark, Professor · CHU de Bordeaux, Groupe Hospitalier Pellegrin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01856998 on ClinicalTrials.gov