NCT04673474

A Food-Effect Study of Hemay022 in Healthy Participants

A PhaseⅠFood-Effect Study of Hemay022 in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Tianjin Hemay Oncology Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of Hemay022 following single dose administration with and without a meal.

Conditions

• Food-drug Interaction

Interventions

Type	Name	Description
DRUG	Hemay022	Participants will receive a single oral dose of Hemay022 tablet in fasted condition on Day 1 of treatment period 1 followed by a single oral dose of Hemay022 tablet in fed condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods.
DRUG	Hemay022	Participants will receive a single oral dose of Hemay022 tablet in fed condition on Day 1 of treatment period 1 followed by a single oral dose of Hemay022 tablet in fasted condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods.

Timeline

• Start date: 2020-12-09
• Primary completion: 2021-02-04
• Completion: 2021-05-01
• First posted: 2020-12-17
• Last updated: 2021-04-20

Locations

1 site across 1 country: China