Relative Bioavailability Study of Amlodipine Powder for Oral Solution, 5 mg (Base) Under Fasting and Fed Conditions
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Brillian Pharma Inc.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- AUC0-inf
Overview
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:
- 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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult, Healthy
Exclusion Criteria
- Not provided
Arms & Interventions
T1 Fasting
Giving test product under fasting condition
Intervention: Amlodipine Freeze-Dried Powder for Oral Solution 5 mg (Drug)
T2 Fed
Giving test product under fed condition
Intervention: Amlodipine Freeze-Dried Powder for Oral Solution 5 mg (Drug)
R Fasting
Giving reference product under fasting condition
Intervention: Norvasc 5 mg tablets of Pfizer Labs (Drug)
Outcomes
Primary Outcomes
AUC0-inf
Time Frame: 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.
AUC0-t
Time Frame: 50 days
Area under the plasma concentration-time curve measured to the last quantifiable concentration, using the linear trapezoidal rule.
Cmax
Time Frame: 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
Secondary Outcomes
- Tmax(6 days)
- t1/2(6 days)
- 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)
- Kel(6 days)
- 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)