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Clifutinib Food Effect Study in Healthy Subjects

NCT05454098 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-03-21

No results posted yet for this study

Summary

The purpose of this study is to evaluate to determine the effect of food on the PK of a single dose of 40 mg Clifutinib in healthy subjects.

Conditions

  • Acute Myeloid Leukemia in Children

Interventions

DRUG

Clifutinib with fed state

40 mg Clifutinib with food

DRUG

Clifutinib with fasted state

40 mg Clifutinib without food

Sponsors & Collaborators

  • Sunshine Lake Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-11-08
Primary Completion
2022-12-08
Completion
2022-12-08

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 NCT05454098 on ClinicalTrials.gov