HypertensionPhase 1NCT05808725
Amlodipine Freeze-Dried Powder for Oral Solution 5 mg
A Phase 1 study testing Amlodipine Freeze-Dried Powder for Oral Solution 5 mg and Norvasc 5 mg tablets of Pfizer Labs in people with Hypertension and Coronary Artery Disease, run by Brillian Pharma Inc. at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Coronary Artery Disease
- What is being tested?
- Amlodipine Freeze-Dried Powder for Oral Solution 5 mg and Norvasc 5 mg tablets of Pfizer Labs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- 29 Dec 2022to 17 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult, Healthy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
India1 site
Accutest Research Laboratories (I) Pvt. Ltd.
Vadodara, Gujarat, 390016
About this study
Official title: Relative Bioavailability Study of Amlodipine Powder for Oral Solution, 5 mg (Base) Under Fasting and Fed Conditions
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:
- To compare the relative bioavailability.
- 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).
Read the 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.
- Conditions
- Hypertension, Coronary Artery Disease
- Being tested
- Amlodipine Freeze-Dried Powder for Oral Solution 5 mg, Norvasc 5 mg tablets of Pfizer Labs
- Medical subject headings
- Hypertension, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine Freeze-Dried Powder for Oral Solution 5 mgDrug
Also called Amlodipine Oral Solution 5 mg
Amlodipine Oral Solution 5 mg is given to T1 Fasting and T2 Fed
Norvasc 5 mg tablets of Pfizer LabsDrug
Also called Amlodipine Besylate 5 mg
Norvasc 5 mg is given to R Fasting
| Study group | Role | What they receive |
|---|---|---|
| T1 Fasting | Experimental | Giving test product under fasting condition Receives: Drug: Amlodipine Freeze-Dried Powder for Oral Solution 5 mg |
| T2 Fed | Experimental | Giving test product under fed condition Receives: Drug: Amlodipine Freeze-Dried Powder for Oral Solution 5 mg |
| R Fasting | Active comparator | Giving reference product under fasting condition Receives: Drug: Norvasc 5 mg tablets of Pfizer Labs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed drug concentration during the study
Measured: 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
Area under the plasma concentration-time curve measured to the last quantifiable concentration, using the linear trapezoidal rule.
Measured: 50 days
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.
Measured: 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 outcomes (5)
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.
Measured: 6 days
AUC0-t/AUC0-inf
Ratio of AUC0-t and AUC0-inf
Measured: 1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose
Residual Area
Extrapolated area (AUC0-inf - AUC0-t)/ AUC0-inf
Measured: 1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose
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.
Measured: 6 days
t1/2
Terminal half-life as determined by quotient 0.693/Kel
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start29 Dec 2022
- Primary completion17 Apr 2023
- Study completion17 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A Randomized, Open Label, Balanced, Three Treatment, Three period, Three Sequence, Single Dose, Crossover design.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brillian Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Accutest Research Laboratories (I) Pvt. Ltd.
- Responsible party
- Sponsor
- Investigators
- Pratikkumar Dilipbhai Asari, M.D., Principal investigator, Accutest Research Laboratories (I) Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808725
- Sponsor's protocol ID
- ARL-22-073
- Status last verified
- Jun 2023
- First submitted
- 7 Mar 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability Study of Amlodipine Powder for Oral Solution, 5 mg (Base) Under Fasting and Fed Conditions
- ClinicalTrials.gov ID
- NCT05808725
- Acronym / sponsor ID
- ARL-22-073
- Conditions
- Hypertension, Coronary Artery Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Brillian Pharma Inc.Industry (pharma, biotech, devices)
- Collaborators
- Accutest Research Laboratories (I) Pvt. Ltd.
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 17 Apr 2023 (actual)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To compare the relative bioavailability.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A Randomized, Open Label, Balanced, Three Treatment, Three period, Three Sequence, Single Dose, Crossover design.
| Arm | Type | Receives |
|---|---|---|
| T1 Fasting | Experimental | Drug: Amlodipine Freeze-Dried Powder for Oral Solution 5 mgGiving test product under fasting condition |
| T2 Fed | Experimental | Drug: Amlodipine Freeze-Dried Powder for Oral Solution 5 mgGiving test product under fed condition |
| R Fasting | Active comparator | Drug: Norvasc 5 mg tablets of Pfizer LabsGiving reference product under fasting condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult, Healthy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amlodipine Freeze-Dried Powder for Oral Solution 5 mgAlso: Amlodipine Oral Solution 5 mgAmlodipine Oral Solution 5 mg is given to T1 Fasting and T2 Fed | Drug | T1 Fasting, T2 Fed |
| Norvasc 5 mg tablets of Pfizer LabsAlso: Amlodipine Besylate 5 mgNorvasc 5 mg is given to R Fasting | Drug | R Fasting |
Primary outcome
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
AUC0-t
Time frame: 50 days
Area under the plasma concentration-time curve measured to the last quantifiable concentration, using the linear trapezoidal rule.
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.
5 secondary outcomes
Tmax
Time frame: 6 days
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
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
Kel
Time frame: 6 days
t1/2
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pratikkumar Dilipbhai Asari, M.D. principal investigator
Accutest Research Laboratories (I) Pvt. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amlodipine Freeze-Dried Powder for Oral Solution 5 mg and Norvasc 5 mg tablets of Pfizer Labs in people with Hypertension and Coronary Artery Disease, run by Brillian Pharma Inc. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.