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

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

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Cudafol(R) (propofol, 1% [10 mg/mL])
* Drug: Diprivan(R) (propofol, 1% [10 mg/mL])


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test product<br>Propofol solution (1% [10 mg/mL]), via intravenous injection | Drug: Cudafol(R) (propofol, 1% [10 mg/mL])<br>* Test product Cudafol(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes<br>|
| Active Comparator: Reference product<br>Propofol emulsion (1% [10 mg/mL]), via intravenous injection | Drug: Diprivan(R) (propofol, 1% [10 mg/mL])<br>* Reference product Diprivan(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |