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Completed

NCT Number: NCT02713802

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

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

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Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Bioequivalence based on pharmacokinetic parameter: Area Under Curve

    Time frame: 0-24 hours post dose

  2. Bioequivalence based on pharmacokinetic parameter: Cmax

    Time frame: 0-24 hours post dose

Secondary outcomes

  1. Pharmacokinetic parameter: Tmax

    Time frame: 0-24 hours post dose

  2. Incidence of adverse events and tolerability

    Time frame: 7 days post dose

    Number of adverse events and local tolerability

Sponsors and collaborators

Lead sponsor

Cuda Anesthetics, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 21, 2016
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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