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Safety and Pharmacokinetics of SIM0417 Combined With Ritonavir in Healthy Elderly Subjects

NCT05826249 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-04-24

No results posted yet for this study

Summary

This is a non-randomized, open-label, single-dose, Phase I clinical study and plans to enroll 12-20 healthy elderly subjects aged 65 and above, including 3-6 subjects aged 75 and above, both men and women.

Conditions

  • Elder

Interventions

DRUG

SIM0417/Ritonavir

Single oral dose of 750 mg SIM0417 coadministered with 100 mg ritonavir.

Sponsors & Collaborators

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wei Zhao · Qianfoshan Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-07
Primary Completion
2023-09-30
Completion
2023-11-30

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 NCT05826249 on ClinicalTrials.gov