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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02713802

Enrollment

Registered

2016-03-21

Start date

2016-03-31

Completion date

2016-04-30

Last updated

2016-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Brief summary

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

Interventions

DRUGCudafol(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

DRUGDiprivan(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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
Pharmacokinetic parameter: Tmax	0-24 hours post dose	—
Incidence of adverse events and tolerability	7 days post dose	Number of adverse events and local tolerability

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026