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

Cuda Anesthetics

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Cudafol(R) (propofol, 1% [10 mg/mL]); Drug: Diprivan(R) (propofol, 1% [10 mg/mL])

Study type: Interventional

Funder types: Industry

Identifiers

NCT02713802

CUDA-C2015-001

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

8 participants in 2 patient groups

Test product

Experimental group

Description:

Propofol solution (1% \[10 mg/mL\]), via intravenous injection

Treatment:

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

Reference product

Active Comparator group

Description:

Propofol emulsion (1% \[10 mg/mL\]), via intravenous injection

Treatment:

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