NCT06822166

Drug Interactions Trial of Methoxyethyl Etomidate Hydrochloride

A Single-center, Open-label, Single-sequence, Self-crossover Controlled Phase I Clinical Study Evaluating Methoxyethyl Etomidate Hydrochloride Drug Interactions in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Ahon Pharmaceutical Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Interaction Drug Food

Interventions

Type	Name	Description
DRUG	rifampicin	rifampicin capsule，600 mg
DRUG	Fluconazole	Fluconazole capsules: 400 mg for the first dose and 200 mg for the remaining doses
DRUG	Omeprazole	Omeprazole enteric-coated capsules: 20 mg
DRUG	midazolam	midazolam injection 0.05 mg/kg was administered intravenously
DRUG	ET-26	the dose is 0.8 mg/kg, single dose, Infusion time was 60seconds ± 5seconds

Timeline

• Start date: 2023-12-04
• Primary completion: 2024-01-23
• Completion: 2024-01-23
• First posted: 2025-02-12
• Last updated: 2025-02-14

Locations

1 site across 1 country: China