Bioequivalence Study of Amlodipine and Norvasc Under Fasting and FED Conditions in Chinese Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 23, 2016

Primary Completion Date

March 21, 2017

Study Completion Date

March 21, 2017

Conditions
Bioequivalence
Interventions
DRUG

LANDI-Amlodipine Besylate Tablet 5mg

LANDI-Amlodipine Besylate Tablet 5mg is a generic product manufactured by YangTZE River Pharmaceutical Group Shanghai Haini Pharmaceutical Co., Ltd.

DRUG

Norvasc Tablets 5mg

Norvasc Tablet 5mg will be used as a comparator drug for the BE study.

Trial Locations (1)

201318

Shanghai Haini Pharmaceutical Co., Ltd., Shanghai

All Listed Sponsors
lead

Shanghai Haini Pharmaceutical Co., Ltd.

INDUSTRY

NCT02974439 - Bioequivalence Study of Amlodipine and Norvasc Under Fasting and FED Conditions in Chinese Healthy Volunteers | Biotech Hunter | Biotech Hunter