Amlodipine Freeze-Dried Powder for Oral Solution 5 mg

Brillian Pharma

Status and phase: Completed; Phase 1

Conditions: Coronary Artery Disease; Hypertension

Treatments: Drug: Amlodipine Freeze-Dried Powder for Oral Solution 5 mg; Drug: Norvasc 5 mg tablets of Pfizer Labs

Study type: Interventional

Funder types: Industry

Identifiers

NCT05808725

ARL-22-073

Details and patient eligibility

About

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).

Full description

A total of 24 healthy, adult, male and female human volunteers will be enrolled.

Excluding the screening period, the duration of the clinical phase will be approximately 50 days including a washout period of at least 21 days for each study period.

This study is being conducted in healthy, adult, human subjects under fasting and fed conditions as per USFDA and NMPA guidelines. The present study will be conducted to assess the relative bioavailability of the test product versus the reference product under fasting conditions. The study also assesses the effect of food on the bioavailability of Amlodipine FD-POS 5 mg (Powder in a Unit-dose container) product.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Adult, Healthy

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

T1 Fasting

Experimental group

Description:

Giving test product under fasting condition

Treatment:

Drug: Amlodipine Freeze-Dried Powder for Oral Solution 5 mg

T2 Fed

Experimental group

Description:

Giving test product under fed condition

Treatment:

Drug: Amlodipine Freeze-Dried Powder for Oral Solution 5 mg

R Fasting

Active Comparator group

Description:

Giving reference product under fasting condition

Treatment:

Drug: Norvasc 5 mg tablets of Pfizer Labs