Amlodipine Freeze-Dried Powder for Oral Solution 5 mg

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).

Timeline

Start

2022-12-29

Primary completion

2023-04-17

Completion

2023-04-17

Drugs

Indications