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

An Open-Label, Randomized, Two-Way Crossover Pilot Study of the Bioequivalence of Cudafol(R) and Diprivan(R) IV Administered as Single Intravenous Doses in Healthy Subjects

Evaluate pharmacokinetic/pharmacodynamic equivalence and safety and tolerability of single doses of Cudafol(R) and Diprivan(R) in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Cudafol(R) (propofol, 1% [10 mg/mL]); Drug: Diprivan(R) (propofol, 1% [10 mg/mL])

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Non-obese men and women, 18 to 55 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. Females of child-bearing potential must be using an approved contraceptive method.

Exclusion Criteria:

• Evidence or history of clinically significant disease.
• History or presence of clinically significant abnormal 12-lead electrocardiogram (ECG), blood pressure, or heart rate.
• Pregnant or nursing (lactating) women.
• Known hypersensitivity or allergy to propofol (or components of either formulation, including eggs, soybean oil or betadex sulfobutyl ether sodium) or any other forms of anesthesia, or has had a reaction to anesthesia in the past.
• Family history of malignant hyperthermia.
• History of drug or alcohol abuse (or tests positive at screening) or current smoker.
• Poor venous access in either arm.
• Tests positive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody.

Other protocol defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test product; Propofol solution (1% [10 mg/mL]), via intravenous injection	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
Active Comparator: Reference product; Propofol emulsion (1% [10 mg/mL]), via intravenous injection	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence based on pharmacokinetic parameter: Area Under Curve	0-24 hours post dose
Bioequivalence based on pharmacokinetic parameter: Cmax	0-24 hours post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic parameter: Tmax		0-24 hours post dose
Incidence of adverse events and tolerability	Number of adverse events and local tolerability	7 days post dose

Collaborators and Investigators

• Sponsor: Cuda Anesthetics, LLC

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: January 15, 2016
• First Submitted That Met QC Criteria: March 15, 2016
• First Posted (Estimate): March 21, 2016

Study Record Updates

• Last Update Posted (Estimate): April 21, 2016
• Last Update Submitted That Met QC Criteria: April 20, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: CUDA-C2015-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO