Amlodipine Freeze-Dried Powder for Oral Solution 5 mg

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05808725
• Other study ID #: ARL-22-073
• Status: Completed
• Phase: Phase 1
• Start date: December 29, 2022
• Est. completion date: April 17, 2023

Study information

• Verified date: June 2023
• Source: Brillian Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 17, 2023
• Est. primary completion date: April 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult, Healthy

Related Conditions & MeSH terms

• Coronary Artery Disease
• Hypertension

Intervention

Drug:
• Amlodipine Freeze-Dried Powder for Oral Solution 5 mg
Amlodipine Oral Solution 5 mg is given to T1 Fasting and T2 Fed
• Norvasc 5 mg tablets of Pfizer Labs
Norvasc 5 mg is given to R Fasting

Locations

Country	Name	City	State
India	Accutest Research Laboratories (I) Pvt. Ltd.	Vadodara	Gujarat

Sponsors (2)

Lead Sponsor	Collaborator
Brillian Pharma Inc.	Accutest Research Laboratories (I) Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	AUC0-t	Area under the plasma concentration-time curve measured to the last quantifiable concentration, using the linear trapezoidal rule.	50 days
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	t1/2	Terminal half-life as determined by quotient 0.693/Kel	6 days