Drug-Drug InteractionPhase 1NCT03390465
Drug Interaction Study of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects
A Phase 1 study testing Fimasartan/Amlodipine combination drug, Hydrochlorothiazide in people with Drug-Drug Interaction, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the Drug interaction and safety of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug-Drug Interaction
- What is being tested?
- Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Dec 2017to 30 Jan 2018
- 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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A healthy Male adults aged 19-50 years
Who cannot join
- History or presence of clinically significant medical or psychiatric condition or disease.
- Hypersensitivity to ingredient of IP and other medication, food.
- Participation in any other study within 3months.
- History of whole blood donation within 2months and Apheresis 1month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Single Dose, 6-Sequence, 3-Period, Cross-over Study to Evaluate a Drug Interaction Between Fixed-dose Combination of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male Subjects
The purpose of this study is to evaluate the Drug interaction and safety of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male volunteers.
- Conditions
- Drug-Drug Interaction
- Being tested
- Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fimasartan/Amlodipine combination drug, HydrochlorothiazideDrug
Also called FAH
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
| Study group | Role | What they receive |
|---|---|---|
| Arm1(N=6) | Other | Fimasartan/Amlodipine combination drug, Hydrochlorothiazide Receives: Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide |
| Arm2(N=6) | Other | Fimasartan/Amlodipine combination drug, Hydrochlorothiazide Receives: Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide |
| Arm3(N=6) | Other | Fimasartan/Amlodipine combination drug, Hydrochlorothiazide Receives: Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide |
| Arm4(N=6) | Other | Fimasartan/Amlodipine combination drug, Hydrochlorothiazide Receives: Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide |
| Arm5(N=6) | Other | Fimasartan/Amlodipine combination drug, Hydrochlorothiazide Receives: Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide |
| Arm6(N=6) | Other | Fimasartan/Amlodipine combination drug, Hydrochlorothiazide Receives: Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma
Measured: 0~48hours after medication
Secondary outcomes (1)
AUCt
AUCt(Area under the curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine, Hydrochlorothiazide
Measured: 0~48hours after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start15 Dec 2017
- Primary completion16 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Drug InteractionStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eun-Young Kim, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390465
- Sponsor's protocol ID
- BR1010
- Status last verified
- Aug 2018
- First submitted
- 29 Dec 2017
- Last updated
- 10 Aug 2018
- 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 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single Dose, 6-Sequence, 3-Period, Cross-over Study to Evaluate a Drug Interaction Between Fixed-dose Combination of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03390465
- Acronym / sponsor ID
- BR1010
- Conditions
- Drug-Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 16 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 4 Jan 2018 (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 evaluate the Drug interaction and safety of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm1(N=6) | Other | Drug: Fimasartan/Amlodipine combination drug, HydrochlorothiazideFimasartan/Amlodipine combination drug, Hydrochlorothiazide |
| Arm2(N=6) | Other | Drug: Fimasartan/Amlodipine combination drug, HydrochlorothiazideFimasartan/Amlodipine combination drug, Hydrochlorothiazide |
| Arm3(N=6) | Other | Drug: Fimasartan/Amlodipine combination drug, HydrochlorothiazideFimasartan/Amlodipine combination drug, Hydrochlorothiazide |
| Arm4(N=6) | Other | Drug: Fimasartan/Amlodipine combination drug, HydrochlorothiazideFimasartan/Amlodipine combination drug, Hydrochlorothiazide |
| Arm5(N=6) | Other | Drug: Fimasartan/Amlodipine combination drug, HydrochlorothiazideFimasartan/Amlodipine combination drug, Hydrochlorothiazide |
| Arm6(N=6) | Other | Drug: Fimasartan/Amlodipine combination drug, HydrochlorothiazideFimasartan/Amlodipine combination drug, Hydrochlorothiazide |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- A healthy Male adults aged 19-50 years
Key exclusion criteria (4 listed)
- History or presence of clinically significant medical or psychiatric condition or disease.
- Hypersensitivity to ingredient of IP and other medication, food.
- Participation in any other study within 3months.
- History of whole blood donation within 2months and Apheresis 1month.
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 |
|---|---|---|
| Fimasartan/Amlodipine combination drug, HydrochlorothiazideAlso: FAHFimasartan/Amlodipine combination drug, Hydrochlorothiazide | Drug | Arm1(N=6), Arm2(N=6), Arm3(N=6), Arm4(N=6), Arm5(N=6), Arm6(N=6) |
Primary outcome
Cmax
Time frame: 0~48hours after medication
Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma
1 secondary outcome
AUCt
Time frame: 0~48hours after medication
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 10 Aug 2018.
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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.
Eun-Young Kim principal investigator
Inje University
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 Fimasartan/Amlodipine combination drug, Hydrochlorothiazide in people with Drug-Drug Interaction, run by Boryung Pharmaceutical Co., Ltd 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 1 inclusion and 4 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 10 Aug 2018. 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?
Cmax (time frame: 0~48hours after medication). 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 10 Aug 2018.