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Safety and Pharmacokinetics/ Pharmacodynamics of Methoxyethyl Etomidate Hydrochloride in Healthy Elderly Subjects

NCT06764147 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-01-24

No results posted yet for this study

Summary

16 subjects were divided into two groups: One group consisted of healthy non-elderly subjects aged 18-64 years (including boundary value). The other group was healthy elderly subjects, aged ≥65 years old, of which no less than 3 cases were ≥75 years old, with 8 subjects in each group.Healthy non-elderly subjects will be included as matched control subjects. The gender of healthy non-elderly subjects was consistent with that of healthy elderly subjects. The mean body weight of the healthy non-elderly subjects was within the range of the mean body weight of the healthy elderly subjects ±10 kg.

All patients received a single intravenous injection of 0.8mg/kg ET-26. To evaluate the pharmacokinetic characteristics of ET-26 and provide guidance for the clinical application of ET-26-hcl.

Conditions

  • Healthy Elderly Subjects

Interventions

DRUG

ET-26HCl

The dose is 0.8 mg/kg, single dose, Infusion time was 60s ± 5s.

Sponsors & Collaborators

  • Ahon Pharmaceutical Co., Ltd.

    lead OTHER

Principal Investigators

  • Wei Zhao, Pharmaciae Doctor · The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-25
Primary Completion
2024-02-02
Completion
2024-02-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06764147 on ClinicalTrials.gov