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Pharmacokinetics Profiles of HQP1351 Under Fasting and High-fat Meals in Patients With Chronic Myeloid Leukemia

NCT03882281 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-01-22

No results posted yet for this study

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.).

Conditions

  • Chronic Myeloid Leukemia, Chronic Phase

Interventions

DRUG

HQP1351

Orally, single dose of 30mg on day 1 and day 8.

Sponsors & Collaborators

  • HealthQuest Pharma Inc.

    collaborator INDUSTRY

  • Ascentage Pharma Group Inc.

    lead INDUSTRY

Principal Investigators

  • QIAN JIANG, Professor · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-25
Primary Completion
2019-11-16
Completion
2019-11-16

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 NCT03882281 on ClinicalTrials.gov