NCT06619873

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

A Phase 1, Open-Label, Single-Dose, Randomized, Four-Period Crossover Study to Evaluate the Relative Bioavailability and Food Effect of HRS-8080 in Healthy Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

• Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-10-10
• Primary completion: 2024-10-30
• Completion: 2024-11-15
• First posted: 2024-10-01
• Last updated: 2024-10-01

Locations

1 site across 1 country: China