Bioequivalence Study of Propofol Medium and Long Chain Fat Emulsion Injection in Healthy Chinese Subjects

July 9, 2025 updated by: Haisco Pharmaceutical Group Co., Ltd.

Bioequivalence and Safety Study of Propofol Medium and Long Chain Fat Emulsion Injection in Healthy Chinese Subjects : A Randomized, Open-label, Single-dose, Cross-over Study

This study assessed the bioequivalence and safety of a single dose of Propofol Medium/Long Chain Fat Emulsion Injection (Test product, Haisco Pharmaceutical Group Co., Ltd.) compared to the reference product (Propofol Medium/Long Chain Fat Emulsion Injection, Fresenius Kabi Deutschland GmbH) in healthy Chinese subjects. Additionally, the pharmacodynamic profiles of both formulations were evaluated

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • The First Affiliated Hospital of Zhengzhou University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy Chinese male or female participants aged 18-55 years (inclusive).
  2. Body weight ≥50.0 kg (male) or ≥45.0 kg (female), with a body mass index (BMI) of 19.0-26.0 kg/m² (inclusive).
  3. No potential difficult airway or loose teeth.
  4. No history of anesthesia-related complications or adverse events.
  5. Normal or clinically nonsignificant findings in: physical examination, vital signs, laboratory tests (including complete blood count, urinalysis, blood biochemistry, coagulation profile, and pregnancy test for all females), 12-lead electrocardiogram (ECG), eligibility confirmed by the investigator despite minor abnormalities.
  6. Participants (and their partners) agree to use effective contraception and avoid pregnancy plans from signing the informed consent form until 3 months after the last dose of the investigational product.
  7. Capable of comprehending study procedures, willing to provide written informed consent, and able to comply with the trial protocol.

Exclusion Criteria:

  1. History or presence of clinically significant diseases affecting major systems (e.g., digestive, respiratory, urinary, cardiovascular, endocrine, neurological, hematological, immunological, psychiatric, or metabolic disorders), familial genetic disorders, or any condition deemed by the investigator to interfere with study outcomes.
  2. Severe infection, trauma, or major surgery within 4 weeks prior to screening, or planned surgical procedures during the study period.
  3. History of drug abuse (e.g., chronic use of NSAIDs, opioids, sedatives, or addictive substances) within 12 months prior to screening, or positive urine drug screen.
  4. Hypersensitivity (e.g., drug/food allergies) or known allergy to propofol or excipients in propofol medium/long-chain triglyceride emulsion (e.g., soybean oil, medium-chain triglycerides, egg lecithin, glycerol, oleic acid, sodium hydroxide).
  5. Excessive alcohol consumption (defined as >14 units/week; 1 unit = 360 mL beer, 45 mL 40% spirits, or 150 mL wine) within 6 months prior to screening, positive alcohol test, or unwillingness to abstain from alcohol during the study.
  6. Smoking >5 cigarettes/day within 3 months prior to screening or inability to abstain from smoking during the study.
  7. Use of prescription drugs, over-the-counter (OTC) medications, supplements (including vitamins), or herbal remedies within 2 weeks prior to screening.
  8. Participation in another clinical trial within 3 months prior to screening, ongoing follow-up in another study, or planned enrollment in other trials during this study.
  9. History or current diagnosis of autonomic dysfunction (e.g., recurrent syncope, palpitations) within the past 3 years.
  10. Severe sleep apnea syndrome.
  11. Positive serological tests for HBsAg, HCV antibodies, Treponema pallidum antibodies, or HIV antibodies.
  12. Family history of malignant hyperthermia.
  13. Hemophobia, needle phobia, or inability to tolerate venipuncture.
  14. Lactating females or positive pregnancy test during screening or the study period.
  15. Dietary restrictions incompatible with study center meals or protocol requirements.
  16. Consumption of specific foods/beverages (e.g., grapefruit, xanthine-containing products) or substances affecting drug ADME (absorption, distribution, metabolism, excretion) within 48 hours prior to dosing.
  17. Any other condition deemed by the investigator to compromise subject safety or data validity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test formulation
Propofol Medium and Long Chain Fat Emulsion Injection (20 mL:0.2g) Manufacturer: Haisco Pharmaceutical Group Co., Ltd
Drug: Tested Propofol Medium and Long Chain Fat Emulsion Injection (T)
Single-dose intravenous infusion of the test formulation under fasting conditions at 30 μg/kg/min. Infusion time: 30 minutes. Dosage: 900 μg/kg for both administrations
Experimental: Reference formulation
Propofol Medium and Long Chain Fat Emulsion Injection (20 mL:0.2g) Manufacturer: Fresenius Kabi Deutschland GmbH
Drug: Reference Propofol Medium and Long Chain Fat Emulsion Injection (R)
Single-dose intravenous infusion of the reference formulation under fasting conditions at 30 μg/kg/min. Infusion time: 30 minutes. Dosage: 900 μg/kg for both administrations

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: From the start of intravenous infusion to 480 minutes after the intravenous infusion
The maximum blood concentration, the pharmacokinetic parameters of Propofol in plasma
From the start of intravenous infusion to 480 minutes after the intravenous infusion
AUC(0-t)
Time Frame: From the start of intravenous infusion to 480 minutes after the intravenous infusion
The area under the blood concentration-time curve from time 0 to the last accurately measurable concentration at sample collection time t was measured, the pharmacokinetic parameters of Propofol in plasma
From the start of intravenous infusion to 480 minutes after the intravenous infusion
AUC(0-∞)
Time Frame: From the start of intravenous infusion to 480 minutes after the intravenous infusion
The area under the blood concentration-time curve from 0 to infinite time (∞), the pharmacokinetic parameters of Propofol in plasma
From the start of intravenous infusion to 480 minutes after the intravenous infusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AEs
Time Frame: From the time of signing ICF to the end of follow-up，up to 10 days
The incidence and severity of AEs
From the time of signing ICF to the end of follow-up，up to 10 days
BIS AUC0-60min
Time Frame: From the start of intravenous infusion to 60 minutes after the intravenous infusion
Area under the BIS positive peak-time curve from 0 to 60 minutes after converting the BIS value to a positive peak (100-BIS)
From the start of intravenous infusion to 60 minutes after the intravenous infusion
BISmin
Time Frame: From the start of intravenous infusion to 60 minutes after the intravenous infusion
Minimum BIS value
From the start of intravenous infusion to 60 minutes after the intravenous infusion
t-BISmin
Time Frame: From the start of intravenous infusion to 60 minutes after the intravenous infusion
Time to reach the minimum BIS value
From the start of intravenous infusion to 60 minutes after the intravenous infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Haisco Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 22, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSK-54-BE-2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings