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Amlodipine Freeze-Dried Powder for Oral Solution 5 mg

NCT05808725 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-06-07

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Amlodipine Freeze-Dried Powder for Oral Solution 5 mg

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

DRUG

Norvasc 5 mg tablets of Pfizer Labs

Norvasc 5 mg is given to R Fasting

Sponsors & Collaborators

  • Accutest Research Laboratories (I) Pvt. Ltd.

    collaborator INDUSTRY

  • Brillian Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Pratikkumar Dilipbhai Asari, M.D. · Accutest Research Laboratories (I) Pvt. Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-29
Primary Completion
2023-04-17
Completion
2023-04-17
FDA Drug
Yes

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05808725 on ClinicalTrials.gov