Coronary Artery Disease, Hypertension
Conditions
Brief 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).
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.
Interventions
DRUGAmlodipine Freeze-Dried Powder for Oral Solution 5 mg
Amlodipine Oral Solution 5 mg is given to T1 Fasting and T2 Fed
DRUGNorvasc 5 mg tablets of Pfizer Labs
Norvasc 5 mg is given to R Fasting
Sponsors
Accutest Research Laboratories (I) Pvt. Ltd.
Brillian Pharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
A Randomized, Open Label, Balanced, Three Treatment, Three period, Three Sequence, Single Dose, Crossover design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult, Healthy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose | Maximum observed drug concentration during the study |
| AUC0-t | 50 days | Area under the plasma concentration-time curve measured to the last quantifiable concentration, using the linear trapezoidal rule. |
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kel | 6 days | 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. |
| Tmax | 6 days | 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. |
| t1/2 | 6 days | Terminal half-life as determined by quotient 0.693/Kel |
| 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 | Ratio of AUC0-t and AUC0-inf |
| Residual Area | 1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose | Extrapolated area (AUC0-inf - AUC0-t)/ AUC0-inf |
Countries
India
Outcome results
None listed