Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

June 11, 2018

Primary Completion Date

January 9, 2019

Study Completion Date

January 9, 2019

Conditions
Lung Cancer
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

Trial Locations (1)

201508

Shanghai Public Health Clinical Center, Shanghai

All Listed Sponsors
lead

Betta Pharmaceuticals Co., Ltd.

INDUSTRY

NCT03536481 - Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers | Biotech Hunter | Biotech Hunter