Amlodipine Freeze-Dried Powder for Oral Solution 5 mg
Status:
Active, not recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical study is to assess the relative bioavailability of Amlodipine for
Oral Solution 5 mg of Brillian Pharma Inc. under fasting and fed conditions versus reference
product Norvasc 5 mg tablets of Pfizer Labs under fasting in normal, healthy, adult, male,
Primary Objective:
1. To compare the relative bioavailability.
2. To assess the food effect in Test product (T1) (Fast) vs Test product (T2) (Fed)
Amlodipine Oral Solution 5 mg of Brillian Pharma Inc.
Secondary Objective:
To monitor the safety and tolerability of a single oral dose of investigational medicinal
products (IMPs).