Amlodipine Freeze-Dried Powder for Oral Solution 5 mg
- Conditions
- HypertensionCoronary Artery Disease
- Interventions
- Registration Number
- NCT05808725
- Lead Sponsor
- Brillian Pharma Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Adult, Healthy
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description T2 Fed Amlodipine Freeze-Dried Powder for Oral Solution 5 mg Giving test product under fed condition R Fasting Norvasc 5 mg tablets of Pfizer Labs Giving reference product under fasting condition T1 Fasting Amlodipine Freeze-Dried Powder for Oral Solution 5 mg Giving test product under fasting condition
- Primary Outcome Measures
Name Time Method 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.
AUC0-t 50 days Area under the plasma concentration-time curve measured to the last quantifiable concentration, using the linear trapezoidal rule.
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
- Secondary Outcome Measures
Name Time Method 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
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
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.
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
Trial Locations
- Locations (1)
Accutest Research Laboratories (I) Pvt. Ltd.
🇮🇳Vadodara, Gujarat, India