Amlodipine Freeze-Dried Powder for Oral Solution 5 mg

Relative Bioavailability Study of Amlodipine Powder for Oral Solution, 5 mg (Base) Under Fasting and Fed Conditions

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).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Hypertension
• Intervention / Treatment: Drug: Amlodipine Freeze-Dried Powder for Oral Solution 5 mg; Drug: Norvasc 5 mg tablets of Pfizer Labs

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Vadodara, Gujarat, India, 390016
      • Accutest Research Laboratories (I) Pvt. Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult, Healthy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T1 Fasting; Giving test product under fasting condition	Drug: Amlodipine Freeze-Dried Powder for Oral Solution 5 mg; Amlodipine Oral Solution 5 mg is given to T1 Fasting and T2 Fed; Other Names: Amlodipine Oral Solution 5 mg
Experimental: T2 Fed; Giving test product under fed condition	Drug: Amlodipine Freeze-Dried Powder for Oral Solution 5 mg; Amlodipine Oral Solution 5 mg is given to T1 Fasting and T2 Fed; Other Names: Amlodipine Oral Solution 5 mg
Active Comparator: R Fasting; Giving reference product under fasting condition	Drug: Norvasc 5 mg tablets of Pfizer Labs; Norvasc 5 mg is given to R Fasting; Other Names: Amlodipine Besylate 5 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum observed drug concentration during the study	1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose
AUC0-t	Area under the plasma concentration-time curve measured to the last quantifiable concentration, using the linear trapezoidal rule.	50 days
AUC0-inf	AUC0-t plus additional area extrapolated to infinity, calculated using the formula AUC0-t + Ct/Kel , where Ct is the last measurable drug concentration and Kel is the elimination rate constant.	1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	Time to observe maximum drug concentration. If the maximum value occurs at more than 1 time point, Tmax is defined as the first time point with this value.	6 days
AUC0-t/AUC0-inf	Ratio of AUC0-t and AUC0-inf	1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose
Residual Area	Extrapolated area (AUC0-inf - AUC0-t)/ AUC0-inf	1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose
Kel	Apparent first - order terminal elimination rate constant calculated from a semi-log plot of the plasma concentration versus time curve, using the method of least square regression.	6 days
t1/2	Terminal half-life as determined by quotient 0.693/Kel	6 days

Collaborators and Investigators

• Sponsor: Brillian Pharma Inc.
• Collaborators: Accutest Research Laboratories (I) Pvt. Ltd.
• Investigators: Principal Investigator: Pratikkumar Dilipbhai Asari, M.D., Accutest Research Laboratories (I) Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2022
• Primary Completion (Actual): April 17, 2023
• Study Completion (Actual): April 17, 2023

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Amlodipine; Pharmaceutical Solutions
• Other Study ID Numbers: ARL-22-073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No