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A Food-Effect Study of Hemay022 in Healthy Participants

NCT04673474 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-04-20

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Tianjin Hemay Oncology Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-12-09
Primary Completion
2021-02-04
Completion
2021-05-31

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 NCT04673474 on ClinicalTrials.gov