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

NCT02974439 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-10-13

No results posted yet for this study

Summary

This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Besylate Tablets 5 mg versus Norvasc 5 mg tablets administered as 5 mg tablet in healthy volunteers with a washout period of 14 days

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.

Sponsors & Collaborators

  • Shanghai Haini Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yanmei Liu · Shanghai Xuhui Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-12-23
Primary Completion
2017-03-21
Completion
2017-03-21

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 NCT02974439 on ClinicalTrials.gov