HealthyPhase 1NCT07057609

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

A Phase 1 study testing Tested Propofol Medium and Long Chain Fat Emulsion Injection (T) and Reference Propofol Medium and Long Chain Fat Emulsion Injection (R) in people with Healthy, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Tested Propofol Medium and Long Chain Fat Emulsion Injection (T) and Reference Propofol Medium and Long Chain Fat Emulsion Injection (R)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteChina
Study dates: 16 Oct 2018to 22 Mar 2019
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy Chinese male or female participants aged 18-55 years (inclusive).
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).
No potential difficult airway or loose teeth.
No history of anesthesia-related complications or adverse events.
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.
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.
Capable of comprehending study procedures, willing to provide written informed consent, and able to comply with the trial protocol.

Who cannot join

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.
Severe infection, trauma, or major surgery within 4 weeks prior to screening, or planned surgical procedures during the study period.
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.
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).
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.
Smoking >5 cigarettes/day within 3 months prior to screening or inability to abstain from smoking during the study.

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Use of prescription drugs, over-the-counter (OTC) medications, supplements (including vitamins), or herbal remedies within 2 weeks prior to screening.
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.
History or current diagnosis of autonomic dysfunction (e.g., recurrent syncope, palpitations) within the past 3 years.
Severe sleep apnea syndrome.
Positive serological tests for HBsAg, HCV antibodies, Treponema pallidum antibodies, or HIV antibodies.
Family history of malignant hyperthermia.
Hemophobia, needle phobia, or inability to tolerate venipuncture.
Lactating females or positive pregnancy test during screening or the study period.
Dietary restrictions incompatible with study center meals or protocol requirements.
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.
Any other condition deemed by the investigator to compromise subject safety or data validity.

Trial locations and contacts

1 site in 1 country.

China1 site

the First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan

Other trials in China

About this study

Official title: 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

Conditions: Healthy
Being tested: Tested Propofol Medium and Long Chain Fat Emulsion Injection (T), Reference Propofol Medium and Long Chain Fat Emulsion Injection (R)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tested Propofol Medium and Long Chain Fat Emulsion Injection (T)Drug
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
Reference Propofol Medium and Long Chain Fat Emulsion Injection (R)Drug
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

Study groups in NCT07057609
Study group	Role	What they receive
Test formulation	Experimental	Propofol Medium and Long Chain Fat Emulsion Injection (20 mL:0.2g) Manufacturer: Haisco Pharmaceutical Group Co., Ltd Receives: Drug: Tested Propofol Medium and Long Chain Fat Emulsion Injection (T)
Reference formulation	Experimental	Propofol Medium and Long Chain Fat Emulsion Injection (20 mL:0.2g) Manufacturer: Fresenius Kabi Deutschland GmbH Receives: Drug: Reference Propofol Medium and Long Chain Fat Emulsion Injection (R)

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax
The maximum blood concentration, the pharmacokinetic parameters of Propofol in plasma
Measured: From the start of intravenous infusion to 480 minutes after the intravenous infusion
AUC(0-t)
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
Measured: From the start of intravenous infusion to 480 minutes after the intravenous infusion
AUC(0-∞)
The area under the blood concentration-time curve from 0 to infinite time (∞), the pharmacokinetic parameters of Propofol in plasma
Measured: From the start of intravenous infusion to 480 minutes after the intravenous infusion

Secondary outcomes (4)

BIS AUC0-60min
Area under the BIS positive peak-time curve from 0 to 60 minutes after converting the BIS value to a positive peak (100-BIS)
Measured: From the start of intravenous infusion to 60 minutes after the intravenous infusion
BISmin
Minimum BIS value
Measured: From the start of intravenous infusion to 60 minutes after the intravenous infusion
t-BISmin
Time to reach the minimum BIS value
Measured: From the start of intravenous infusion to 60 minutes after the intravenous infusion
AEs
The incidence and severity of AEs
Measured: From the time of signing ICF to the end of follow-up，up to 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Oct 201822 Mar 2019

First posted10 Jul 2025
Study start16 Oct 2018
Primary completion19 Dec 2018
Study completion22 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07057609
Sponsor's protocol ID: HSK-54-BE-2018
Status last verified: Jul 2025
First submitted: 30 Jun 2025
Last updated: 14 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07057609
Acronym / sponsor ID: HSK-54-BE-2018
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
Study start: 16 Oct 2018 (actual)
Primary completion: 19 Dec 2018 (actual)
Study completion: 22 Mar 2019 (actual)
First posted: 10 Jul 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Test formulation	Experimental	Drug: Tested Propofol Medium and Long Chain Fat Emulsion Injection (T)Propofol Medium and Long Chain Fat Emulsion Injection (20 mL:0.2g) Manufacturer: Haisco Pharmaceutical Group Co., Ltd
Reference formulation	Experimental	Drug: Reference Propofol Medium and Long Chain Fat Emulsion Injection (R)Propofol Medium and Long Chain Fat Emulsion Injection (20 mL:0.2g) Manufacturer: Fresenius Kabi Deutschland GmbH

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Healthy Chinese male or female participants aged 18-55 years (inclusive).
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).
No potential difficult airway or loose teeth.
No history of anesthesia-related complications or adverse events.
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.

Key exclusion criteria (17 listed)

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.
Severe infection, trauma, or major surgery within 4 weeks prior to screening, or planned surgical procedures during the study period.
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.
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).
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Drug	Test formulation
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	Drug	Reference formulation

Primary outcome

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
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
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

4 secondary outcomes

BIS AUC0-60min
Time frame: 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
t-BISmin
Time frame: From the start of intravenous infusion to 60 minutes after the intravenous infusion
AEs
Time frame: From the time of signing ICF to the end of follow-up，up to 10 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: From the start of intravenous infusion to 480 minutes after the intravenous infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07057609.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.