Healthy VolunteersPhase 1NCT05663073
Pharmacokinetics of Irbesartan/Amlodipine FDC and Co-administration of Irbesartan and Amlodipine in Healthy Volunteers
A Phase 1 study testing Irbesartan/Amlodipine FDC, Irbesartan and Amlodipine in people with Healthy Volunteers, run by Handok Inc. at 1 site in South Korea.
Trial summary
The purpose of this study is to compare pharmacokinetics and safety of Irbesartan and Amlodipine Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Irbesartan/Amlodipine FDC, Irbesartan and Amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Sep 2022to 21 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are 19 years or older on screening
- Signed informed consent
- Healthy Volunteer
- Other inclusion applies
Who cannot join
- Clinically relevant/significant findings as evaluated by the investigator
- Other exclusion applied
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of Irbesartan/Amlodipine Fixed Dose Combination in Comparison With Co-administration of Mono Compounds in Healthy Volunteers
The purpose of this study is to compare pharmacokinetics and safety of Irbesartan and Amlodipine Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers
- Conditions
- Healthy Volunteers
- Being tested
- Irbesartan/Amlodipine FDC, Irbesartan, Amlodipine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irbesartan/Amlodipine FDCDrug
Irbesartan/Amlodipine FDC
IrbesartanDrug
Co-administration of Irbesartan and Amlodipine
AmlodipineDrug
Co-administration of Irbesartan and Amlodipine
| Study group | Role | What they receive |
|---|---|---|
| Irbesartan/Amlodipine Fixed dose combination | Experimental | participants will receive one tablet of Irbesartan/Amlodipine FDC in a crossover design Receives: Drug: Irbesartan/Amlodipine FDC |
| Co-administration of Irbesartan and Amlodipine | Experimental | participants will receive one table each of Irbesartan and Amlodipine in a crossover design Receives: Drug: Irbesartan; Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of Irbesartan and Amlodipne
Measured: 72 hours
Cmax of Irbesartan and Amlodipne
Measured: 72 hours
Secondary outcomes (6)
AUCinf of Irbesartan and Amlodipine
Measured: 72 hours
AUCt/AUCinf of Irbesartan and Amlodipine
Measured: 72 hours
tmax of Irbesartan and Amlodipine
Measured: 72 hours
half-life of Irbesartan and Amlodipine
Measured: 72 hours
CL/F of Irbesartan and Amlodipine
Measured: 72 hours
Vz/F of Irbesartan and Amlodipine
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start13 Sep 2022
- Primary completion15 Dec 2022
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663073
- Sponsor's protocol ID
- HD-AI-101
- Status last verified
- Aug 2023
- First submitted
- 14 Dec 2022
- Last updated
- 18 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of Irbesartan/Amlodipine Fixed Dose Combination in Comparison With Co-administration of Mono Compounds in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05663073
- Acronym / sponsor ID
- HD-AI-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 23 Dec 2022 (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 purpose of this study is to compare pharmacokinetics and safety of Irbesartan and Amlodipine Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irbesartan/Amlodipine Fixed dose combination | Experimental | Drug: Irbesartan/Amlodipine FDCparticipants will receive one tablet of Irbesartan/Amlodipine FDC in a crossover design |
| Co-administration of Irbesartan and Amlodipine | Experimental | Drug: Irbesartan, Drug: Amlodipineparticipants will receive one table each of Irbesartan and Amlodipine in a crossover design |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are 19 years or older on screening
- Signed informed consent
- Healthy Volunteer
- Other inclusion applies
Key exclusion criteria (2 listed)
- Clinically relevant/significant findings as evaluated by the investigator
- Other exclusion applied
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 |
|---|---|---|
| Irbesartan/Amlodipine FDCIrbesartan/Amlodipine FDC | Drug | Irbesartan/Amlodipine Fixed dose combination |
| IrbesartanCo-administration of Irbesartan and Amlodipine | Drug | Co-administration of Irbesartan and Amlodipine |
| AmlodipineCo-administration of Irbesartan and Amlodipine | Drug | Co-administration of Irbesartan and Amlodipine |
Primary outcome
AUCt of Irbesartan and Amlodipne
Time frame: 72 hours
Cmax of Irbesartan and Amlodipne
Time frame: 72 hours
6 secondary outcomes
AUCinf of Irbesartan and Amlodipine
Time frame: 72 hours
AUCt/AUCinf of Irbesartan and Amlodipine
Time frame: 72 hours
tmax of Irbesartan and Amlodipine
Time frame: 72 hours
half-life of Irbesartan and Amlodipine
Time frame: 72 hours
CL/F of Irbesartan and Amlodipine
Time frame: 72 hours
Vz/F of Irbesartan and Amlodipine
Time frame: 72 hours
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 18 Aug 2023.
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Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Irbesartan/Amlodipine FDC, Irbesartan and Amlodipine in people with Healthy Volunteers, run by Handok Inc. at 1 site in South Korea.
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 4 inclusion and 2 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 18 Aug 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 South Korea. 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?
AUCt of Irbesartan and Amlodipne (time frame: 72 hours). The study lists 2 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 18 Aug 2023.