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Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers

NCT03536481 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2019-07-24

No results posted yet for this study

Summary

The main objective of this study is to evaluate the bioequivalency of two preparations of ensartinib capsules in Chinese healthy volunteers.

Conditions

Interventions

DRUG

ensartinib capsules (test product)

Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals

DRUG

ensartinib capsules (reference product)

Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions

Sponsors & Collaborators

  • Betta Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Tongyu Zhu · Shanghai Public Health Clinical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-06-11
Primary Completion
2019-01-09
Completion
2019-01-09

Countries

  • China

Study Locations

More Related Trials

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 NCT03536481 on ClinicalTrials.gov