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A Study to Investigate the Food Effect on the Pharmacokinetics of Ensartinib Capsules in Chinese Healthy Volunteers.

NCT03510611 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-07-24

No results posted yet for this study

Summary

The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of Ensartinib Capsules.

Conditions

Interventions

DRUG

Ensartinib with fed or fasting

The two groups of subjects were given an equal dose of Ensartinib capsules (225 mg) after a single cross-over fasting or high-fat high-calorie diet in two different test cycles to examine the effect of food on the pharmacokinetics of Ensartinib.

Sponsors & Collaborators

  • Betta Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • zourong ruan · the Second Affiliated Hospital of Zhejiang University Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-03-12
Primary Completion
2018-08-02
Completion
2018-08-02

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT03510611 on ClinicalTrials.gov