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NCT Number: NCT05808725

Amlodipine Freeze-Dried Powder for Oral Solution 5 mg

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).

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Key information

Conditions

Hypertension Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Accutest Research Laboratories (I) Pvt. Ltd.

Vadodara, Gujarat, 390016, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult, Healthy

Treatment and study plan

Amlodipine Freeze-Dried Powder for Oral Solution 5 mg

Drug

Amlodipine Oral Solution 5 mg is given to T1 Fasting and T2 Fed

Other names: Amlodipine Oral Solution 5 mg

Norvasc 5 mg tablets of Pfizer Labs

Drug

Norvasc 5 mg is given to R Fasting

Other names: Amlodipine Besylate 5 mg

Primary outcomes

  1. 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

  2. AUC0-t

    Time frame: 50 days

    Area under the plasma concentration-time curve measured to the last quantifiable concentration, using the linear trapezoidal rule.

  3. 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.

Secondary outcomes

  1. Tmax

    Time frame: 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.

  2. AUC0-t/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

    Ratio of AUC0-t and AUC0-inf

  3. Residual Area

    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

    Extrapolated area (AUC0-inf - AUC0-t)/ AUC0-inf

  4. Kel

    Time frame: 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.

  5. t1/2

    Time frame: 6 days

    Terminal half-life as determined by quotient 0.693/Kel

Sponsors and collaborators

Lead sponsor

Brillian Pharma Inc.

Industry

Collaborators

  • Accutest Research Laboratories (I) Pvt. Ltd.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2023
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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