Sixty-eight healthy subjects were divided into three sequences: A, B and C. The effects of CYP2C19 inhibitor fluconazole and inducer rifampicin on ET-26-HCl injection were evaluated, and the effects of ET-26-HCl injection on pharmacokinetics of omeprazole and midazolam were evaluated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
68
rifampicin capsule,600 mg
Fluconazole capsules: 400 mg for the first dose and 200 mg for the remaining doses
Omeprazole enteric-coated capsules: 20 mg
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)
Jinan, Shandong, China
Pharmacokinetic Parameter(ET-26/ etomidate acid)
Cmax
Time frame: within 1 hour before and 24 hours after the end of ET-26-HCl.from 1 hour before administration of omeprazole enteric-coated capsules until 24 hours after the end of administration.
modified observer's assessment of alert(MOAA/S) score
The lowest score was 0, indicating full anesthetic sedation, and the highest score was 5, indicating full consciousness.
Time frame: up to 10 minutes after drug administration.
bispectral index
BIS values range from 0 to 100, with higher values indicating more wakefulness and lower values indicating more severe cortical inhibition.
Time frame: up to 10 minutes after drug administration.
Eyelash reflex
Gently touching the subject's eyelashes with a cotton swab can cause the subject to blink, that is, there is an eyelash reflex. When the eyelash reflex disappears, the patient has entered a state of anesthesia
Time frame: up to 2 minutes after drug administration.
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midazolam injection 0.05 mg/kg was administered intravenously
the dose is 0.8 mg/kg, single dose, Infusion time was 60seconds ± 5seconds