NCT07057609

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 subjects. Additionally, the pharmacodynamic profiles of both formulations were evaluated

Conditions

• Healthy

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2018-10-16
• Primary completion: 2018-12-19
• Completion: 2019-03-22
• First posted: 2025-07-10
• Last updated: 2025-07-14

Locations

1 site across 1 country: China