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A Phase IIIa Clinical Trial of Fospropofol Disodium for Injection

Pharmacokinetics and pharmacodynamics study of Fospropofol Disodium for Injection in healthy subjects: a single-center, random, open, cross, controlled, two-period clinical trial compared with propofol medium/long chain fat emulsion injection

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016329
Enrollment
Unknown
Registered
2018-05-25
Start date
2017-12-20
Completion date
Unknown
Last updated
2018-05-28

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

Conditions

healthy person

Interventions

group 2:Administration: single intravenous injection
administration time: 60 s. Dosage: 2mg/kg.

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1) Half males and half females; 2) Aged between 18~45 years, the weight is not less than 50kg; BMI 19 to 24; 3) Health, no heart, lung, liver, kidney, kidney, digestive tract, nervous system disease and metabolic abnormalities and physical examination (such as electrocardiogram, blood pressure, heart rate, liver function, kidney function, lung function, blood routine etc.) should not be abnormal; 4) The subjects voluntarily signed the informed consent form of the trial.

Exclusion criteria

Exclusion criteria: 1) People who have drug allergy history, allergic disease, allergic constitution; who have allergy history of narcotic drugs or drugs whos structure be similar to trial drugwho are suspected hereditary history of malignant hyperthermia; who are allergic to eggs, soybeans and their products; who have contraindications of study related drugs; 2) Pregnant, lactating women, or those who have pregnancy plans within 1 months (including male subjects); 3) Systolic pressure140 mmHg; Heart rate120 bpm; Postural hypotension subjects; 4) According to the Fridericia formula, the QT/QTc interval was significantly prolonged (male=470 ms, female =480 ms); 5) People with known or expected difficulty airway; 6) Cognitive dysfunction; 7) Coagulation disorders; 8) People who take any other drugs within two weeks before the beginning of the trial,;smoking, drinking and caffeinated beverages during the test period; 9) People who are suspected or confirmed history of alcohol or substance abuse; 10) People who participated in the drug trial (including the trial drug) within 3 months before the trialor who were repeatedly enrolled in this trial; 11) A sponsor or researcher who directly participates in the trial,or their family members; 12) People who are refused by researchers with any reason.

Design outcomes

Secondary

MeasureTime frame
eyelash reflexes;recovery time;laboratory inspection;Temperature;Pain induced by injection;Other adverse events;

Primary

MeasureTime frame
Pharmacokinetic parameters;BIS;MOAA/S;??????;circulatory system;heart rate;respiratory system;liver function;renal function;

Countries

China

Contacts

Public ContactZhaomeng Wu

West China Hospital, Sichuan University

bugmeng@163.com+86 18980601401

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026