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.).
Name: HQP1351
Description: Orally, single dose of 30mg on day 1 and day 8.Type: DrugA group B group
Description: Area under the plasma concentration-time curve from time zero extrapolated to infinity time of HQP1351.
Measure: Area under the curve from the time of dosing to infinity [AUC(0-inf)] Time: 1-5 days after every drug administrationDescription: Area under the plasma concentration-time curve from time zero to the last measurable time point of HQP1351.
Measure: Area under the curve from the time of dosing to the last measurable concentration [AUC(0-last)] Time: 1-5 days after every drug administrationDescription: Percentage of area under the concentration time curve from time zero extrapolated to infinite time obtained by extrapolation of HQP1351.
Measure: Percentage of AUC(0-inf)_obs due to extrapolation from the last measurable time point to infinity (AUC_%Extrap) Time: 1-5 days after every drug administrationDescription: Maximum observed plasma concentration of HQP1351.
Measure: Maximum observed concentration (Cmax) Time: 1-5 days after every drug administrationDescription: Time to maximum observed plasma concentration of HQP1351.
Measure: Time of maximum observed concentration (Tmax) Time: 1-5 days after every drug administrationDescription: Terminal elimination half life (T1/2) is defined as the duration until observation of half of the maximum concentration of HQP1351.
Measure: Terminal elimination half life (T1/2) Time: 1-5 days after every drug administrationDescription: Apparent clearance of HQP1351 following oral dosing. Clearance of a drug is a measure of rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose of HQP1351 (apparent oral clearance) is influenced by the fraction of dose absorbed.
Measure: Total body clearance for extravascular administration (CL/F) Time: 1-5 days after every drug administrationDescription: Apparent volume of distribution of HQP1351. Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution of HQP1351 after oral dose (Vz/F) is influenced by the fraction absorbed.
Measure: Volume of distribution based on the terminal phase for extravascular administration (Vz/F) Time: 1-5 days after every drug administrationDescription: Incidence of toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Measure: Incidence of toxicity Time: up to 12 daysAllocation: Randomized
Crossover Assignment
There is one SNP
3. Previously treated with and or developed resistance / intolerance to second generation tyrosine kinase inhibitors (TKIs) (dasatinib,nilotinib)or,been identified to have the T315I mutation at any time during treatment. --- T315I ---