Amlodipine Freeze-Dried Powder for Oral Solution 5 mg

Study Overview
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Brief Summary
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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: To compare the relative bioavailability. 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).

Detailed Description
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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.

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

Conditions
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Hypertension, Coronary Artery Disease

Intervention / Treatment
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* Drug: Amlodipine Freeze-Dried Powder for Oral Solution 5 mg
* Drug: Norvasc 5 mg tablets of Pfizer Labs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult, Healthy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A Randomized, Open Label, Balanced, Three Treatment, Three period, Three Sequence, Single Dose, Crossover design.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |