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Clinical Trial Summary

The purpose of this study is to characterize the pharmacokinetics of HQP1351 in participants with resistant chronic myeloid leukemia (CML) in chronic phase (CP) after high-fat and fasting meals separately(Selection of high-fat meal spectrum:《The Food - Effect Bioavailability and Fed Bioequivalence Studies》high fat diet should be 800-1000 kcal heat.).


Clinical Trial Description

The drug being test in this study is HQP1351,the study will characterize the pharmacokinetics of HQP1351 in participants with resistant chronic myeloid leukemia(CML)in chronic phase(CP)after high-fat meal and fasting meal separately at a dose of 30mg,single-dose. The study will enroll 12 subjects totally and be randomly divided into 2 groups(A group and B group). Every group will have 6 subjects. The experiment is divided into two periods,in period 1, subjects in the group A will be given HQP1351 30mg after fasting meal,and the group B will be given HQP1351 30mg after 30 minutes of high-fat meal. Then after a seven-day of cleaning time the two groups of subjects took the drug interchangeably in the period 2. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03882281
Study type Interventional
Source Ascentage Pharma Group Inc.
Contact
Status Completed
Phase Phase 1
Start date March 25, 2019
Completion date November 16, 2019

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