NCT05346601

Trial of Chiauranib Capsule on Pharmacokinetics to Assess the Effect of High Fat Diet in Healthy Volunteers

A Randomized, Open-label, Single-dose, Single-center, Two-sequence, Two- Stage Phase I Trial of Chiauranib Capsule on Pharmacokinetics to Assess the Effect of High Fat Diet in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Chipscreen Biosciences, Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to further study the pharmacokinetic characteristics of Chiauranib Capsule in Healthy Volunteers with High Fat Diet.

Detailed description

This study is a Randomized, Open-label, Single-dose, Single-center, two-sequence, two- stage Phase I Trial. 16 Healthy Volunteers will be enrolled and Randomized into two arms. 8 Healthy Volunteers were in each arm. Arm A：Patients receive 50mg Chiauranib po only once In the fasting state and after 14 days receive 50mg Chiauranib po Only once with High Fat Diet. Arm B: Patients receive 50mg Chiauranib po only once with High Fat Diet and after 14 days receive 50mg Chiauranib po Only once In the fasting state. During the trial, Blood samples were collected.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Chiauranib	50mg po only once

Timeline

• Start date: 2022-06-02
• Primary completion: 2022-06-28
• Completion: 2022-06-28
• First posted: 2022-04-26
• Last updated: 2023-02-09

Locations

1 site across 1 country: China