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Brief Title: Pharmacokinetics Profiles of HQP1351 Under Fasting and High-fat Meals in Patients With Chronic Myeloid Leukemia
Official Title: A Randomized, Open, Double-crossing Trial to Evaluate the Effect of Fasting or High-fat Meals on the Pharmacokinetics of Single Oral Administration of HQP1351 Tablets on an Empty Stomach or a High-fat Meal in Patients With Chronic Myeloid Leukemia
Study ID: NCT03882281
Brief 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.).
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Peking University People's Hospital, Beijing, Beijing, China
Name: QIAN JIANG, Professor
Affiliation: Peking University People's Hospital
Role: PRINCIPAL_INVESTIGATOR