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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02713802
• Other study ID #: CUDA-C2015-001
• Status: Completed
• Phase: Phase 1
• First received: January 15, 2016
• Last updated: April 20, 2016
• Start date: March 2016
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Cuda Anesthetics, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cuda Anesthetics, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence based on pharmacokinetic parameter: Area Under Curve		0-24 hours post dose	No
Primary	Bioequivalence based on pharmacokinetic parameter: Cmax		0-24 hours post dose	No
Secondary	Pharmacokinetic parameter: Tmax		0-24 hours post dose	No
Secondary	Incidence of adverse events and tolerability	Number of adverse events and local tolerability	7 days post dose	Yes