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

NCT02713802 | Completed Phase 1

• 1 other identifier: CUDA-C2015-001
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pharmacokinetic parameter: Tmax

  0-24 hours post dose

• Incidence of adverse events and tolerability

  7 days post dose

Study Arms (2)

Test product

EXPERIMENTAL

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

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

Reference product

ACTIVE COMPARATOR

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

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

Interventions

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

Test product Cudafol(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes

Test product

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

Reference product Diprivan(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes

Reference product

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cuda Anesthetics, LLC: lead

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: March 21, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 21, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share