NCT02713802View on ClinicalTrials.gov

Pilot Study of Bioequivalence of Cudafol(R) and Diprivan(R) Administered as Single Intravenous Doses in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
Healthy Subjects
Interventions
DRUG

Cudafol(R) (propofol, 1% [10 mg/mL])

Test product Cudafol(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes

DRUG

Diprivan(R) (propofol, 1% [10 mg/mL])

Reference product Diprivan(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes

All Listed Sponsors
lead

Cuda Anesthetics, LLC

INDUSTRY

NCT02713802 - Pilot Study of Bioequivalence of Cudafol(R) and Diprivan(R) Administered as Single Intravenous Doses in Healthy Subjects | Biotech Hunter | Biotech Hunter