Overview
Amlodipine Freeze-Dried Powder for Oral Solution 5 mg
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2023-04-01
2023-04-01
Target enrollment:
0
0
Participant gender:
All
All
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).Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Brillian Pharma Inc.Collaborator:
Accutest Research Laboratories (I) Pvt. Ltd.Treatments:
Amlodipine
Pharmaceutical Solutions
Criteria
Inclusion Criteria:- Adult, Healthy