NCT02974439

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

An Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study of Amlodipine and Norvasc Under Fasting Condition Sand Under Non-fasting(FED) Conditions in Chinese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Shanghai Haini Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Detailed description

The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 14 days. During each session, the subjects will be administered a single dose of 5mg amlodipine (one LANDI-Amlodipine Tablet 5mg or one Norvasc Tablet 5mg) under fasting and FED conditions.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-12-23
• Primary completion: 2017-03-21
• Completion: 2017-03-21
• First posted: 2016-11-28
• Last updated: 2017-10-13

Locations

1 site across 1 country: China