Pilot Study of Bioequivalence of Cudafol(R) and Diprivan(R) Administered as Single Intravenous Doses in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy Subjects
- Interventions
- Drug: Diprivan(R) (propofol, 1% [10 mg/mL])Drug: Cudafol(R) (propofol, 1% [10 mg/mL])
- Registration Number
- NCT02713802
- Lead Sponsor
- Cuda Anesthetics, LLC
- Brief Summary
Evaluate pharmacokinetic/pharmacodynamic equivalence and safety and tolerability of single doses of Cudafol(R) and Diprivan(R) in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Reference product Diprivan(R) (propofol, 1% [10 mg/mL]) Propofol emulsion (1% \[10 mg/mL\]), via intravenous injection Test product Cudafol(R) (propofol, 1% [10 mg/mL]) Propofol solution (1% \[10 mg/mL\]), via intravenous injection
- Primary Outcome Measures
Name Time Method 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
Name Time Method Incidence of adverse events and tolerability 7 days post dose Number of adverse events and local tolerability
Pharmacokinetic parameter: Tmax 0-24 hours post dose