Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2022-12-29
2023-04-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Relative Bioavailability Study of Amlodipine Besylate 10 mg Tablets Under Fasting Conditions
NCT00870142
An Comparative Pharmacokinetic Study of Amlodipine Besylate Controlled-release Tablets,China in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions
NCT05667818
A Relative Bioavailability Study of Amlodipine Besylate 10 mg Tablets Tablets Under Fed Conditions
NCT00870571
Bioequivalence Study of Amlodipine Tablets Under Fasting Conditions
NCT00775905
Bioequivalency Study of Amlodipine Tablets Under Fasting Conditions
NCT00602017
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
T1 Fasting
Giving test product under fasting condition
Amlodipine Freeze-Dried Powder for Oral Solution 5 mg
Amlodipine Oral Solution 5 mg is given to T1 Fasting and T2 Fed
T2 Fed
Giving test product under fed condition
Amlodipine Freeze-Dried Powder for Oral Solution 5 mg
Amlodipine Oral Solution 5 mg is given to T1 Fasting and T2 Fed
R Fasting
Giving reference product under fasting condition
Norvasc 5 mg tablets of Pfizer Labs
Norvasc 5 mg is given to R Fasting
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Accutest Research Laboratories (I) Pvt. Ltd.
INDUSTRY
Brillian Pharma Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pratikkumar Dilipbhai Asari, M.D.
Role: PRINCIPAL_INVESTIGATOR
Accutest Research Laboratories (I) Pvt. Ltd.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Accutest Research Laboratories (I) Pvt. Ltd.
Vadodara, Gujarat, India
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ARL-22-073
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.