The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)
Jinan, Shandong, 250014, China
NCT Number: NCT06822166
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.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Jinan, Shandong, 250014, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
Auxiliary examination:
Medication history:
History of disease and surgery:
Living habits:
Others:
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
midazolam injection 0.05 mg/kg was administered intravenously
the dose is 0.8 mg/kg, single dose, Infusion time was 60seconds ± 5seconds
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.
Cmax
Time frame: up to 10 minutes after drug administration.
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.
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 2 minutes after drug administration.
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
Ahon Pharmaceutical Co., Ltd.
Other
A Single-center, Open-label, Single-sequence, Self-crossover Controlled Phase I Clinical Study Evaluating Methoxyethyl Etomidate Hydrochloride Drug Interactions in Healthy Subjects
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