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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02713802
Other study ID # CUDA-C2015-001
Secondary ID
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


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
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