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A Phase 1, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of HRS-8080 in Healthy Subjects

NCT06619873 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-10-01

No results posted yet for this study

Summary

The study is being conducted to evaluate the relative bioavailability of HRS-8080 in the fasted state in healthy adult subjects and to assess the impact of food on HRS-8080 PK for the Phase 3 capsule in healthy adult.

Conditions

Interventions

DRUG

HRS-8080

Medication regimen A Drug: 600mg, Old process tablets，NPO Medication regimen B Drug: 600mg, New process tablets，NPO Medication regimen C Drug: 600mg, New process tablets，PC.，low-fat diet Medication regimen D Drug: 600mg, New process tablets，PC.，high-fat diet

Sponsors & Collaborators

  • Shandong Suncadia Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2024-10-30
Completion
2024-11-15

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT06619873 on ClinicalTrials.gov