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A Study to Evaluate the Bioavailability, Food Effect and Pharmacokinetics of Deuremidevir Hydrobromide for Suspension

NCT05932459 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-11-20

No results posted yet for this study

Summary

This study is divided into three parts: bioavailability study (hereinafter referred to as "BA study"), food effect study (hereinafter referred to as "FE study") and pharmacokinetic characteristics study (hereinafter referred to as "PK characteristics study"). A total of 38 subjects are planned to be enrolled. The three parts of the study can be carried out simultaneously, and there is no order requirement. The subjects will be assigned to one of them according to the enrollment order. Dose selection is 100mg, 300mg and 25mg.

Conditions

  • Healthy Subjects

Interventions

DRUG

Deuremidevir Hydrobromide for Suspension 100mg

Take it with 240ml water in fasted condition.

DRUG

Deuremidevir Hydrobromide for Suspension 300mg

Take it with water in fasted condition or after taking infant formula.

DRUG

Deuremidevir Hydrobromide for Suspension 25mg

Take it with 240ml water on an empty stomach.

DRUG

Deuremidevir Hydrobromide tablets 100mg

Take it with 240ml water in fasted condition.

Sponsors & Collaborators

  • Vigonvita Life Sciences

    lead INDUSTRY

Principal Investigators

  • Jing Zhang · Hushan Hospital of the Fudan university

  • Xiaojie Wu · Hushan Hospital of the Fudan university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

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 NCT05932459 on ClinicalTrials.gov