Status and phase
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About
This is a Phase I, single-center, open-label, randomized,two-way crossover, propofol-controlled, two-stage study evaluating the safety and pharmacokinetics/pharmacodynamics of IV maintenance dose and IV single loade dose plus maintenance dose of HSK3486 emulsion for injection in healthy subjects.
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
Known sensitivity to excipients in HSK3486 injectable emulsion (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate and sodium hydroxide), rifampin, or contraindications mentioned in the prescribing information of rifampin; history of drug allergies (including anesthetics), allergic diseases, or those with hyperactive immune response;
In receipt of any one of the following medications or treatments during screening/baseline:
A history or evidence of any one of the following diseases prior to screening/baseline:
Laboratory results that meet any of the following during screening/baseline:
Positive result for either HBsAg, HCV, HIV, or syphilis;
Abnormal hepatic or renal function confirmed after re-examination;
History of alcohol abuse within 3 months prior to screening, abuse defined as average of > 2 units of alcohol per day (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine), or positive result for breath alcohol test during baseline;
Smoke more than 5 cigarettes per day and a total of more than 60 cigarettes within 3 months prior to screening;
Blood donation or blood loss ≥200 mL within 30 days prior to screening; plasma donation or plasma exchange within 7 days prior to screening;
Subjects who consume any beverages or foods containing alcohol, grapefruit juice or methylxanthine (such as coffee, tea, coca-cola, chocolate, functional drinks), to participate in strenuous physical activities and other factors that may affect drug absorption, distribution, metabolism, and excretion within 2 days prior to enrollment; subjects who are unable to fast for 8 hours prior to dose administration;
Subjects expected to have surgery or hospitalization during the trial;
Subjects unsuitable for arterial blood collection, such as subjects who have positive Allen's test;
Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial; subjects who are planning pregnancy within 1 month after the completion of the trial (including male subjects);
Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.
Primary purpose
Allocation
Interventional model
Masking
16 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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