PharmacokineticsPhase 1NCT03629067
Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects
A Phase 1 study testing Treatment T and Treatment R in people with Pharmacokinetics, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the Pharmacokinetics and safety/tolerability between Fimasartan/Amlodipine/Hydrochlorothiazide and co administration of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Treatment T and Treatment R
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Sep 2018to 27 Dec 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A healthy 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.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 100-744
About this study
Official title: A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between BR1010 and Co-administration of BR1010-1 and BR1010-2 in Healthy Volunteers
The purpose of this study is to evaluate the Pharmacokinetics and safety/tolerability between Fimasartan/Amlodipine/Hydrochlorothiazide and co administration of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy volunteers.
- Conditions
- Pharmacokinetics
- Being tested
- Treatment T, Treatment R
- Keywords
- Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment TDrug
Also called FAH
Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide
Treatment RDrug
Also called FA/H
Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Period 1(Treatment R) - Period 2(Treatment R) - Period 3(Treatment T)
There will be a 14 washout of days between the each period. Receives: Drug: Treatment T; Drug: Treatment R |
| Sequence B | Experimental | Period 1(Treatment R) - Period 2(Treatment T) - Period 3(Treatment R)
There will be a 14 washout of days between the each period. Receives: Drug: Treatment T; Drug: Treatment R |
| Sequence C | Experimental | Period 1(Treatment T) - Period 2(Treatment R) - Period 3(Treatment R)
There will be a 14 washout of days between the each period. Receives: Drug: Treatment T; Drug: Treatment R |
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: 0~144hours after Medication
Secondary outcomes (1)
AUCinf
"Area under the plasma concentration versus time curve " of Fimasartan, Amlodipine, Hydrochlorothiazide
Measured: 0~144hours after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start13 Sep 2018
- Primary completion29 Nov 2018
- Study completion27 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-sang Yu, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629067
- Sponsor's protocol ID
- BR1010(BR-FAHC-CT-102)
- Status last verified
- Jan 2019
- First submitted
- 9 Aug 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between BR1010 and Co-administration of BR1010-1 and BR1010-2 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03629067
- Acronym / sponsor ID
- BR1010(BR-FAHC-CT-102)
- Conditions
- Pharmacokinetics
- Keywords
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 27 Dec 2018 (actual)
- First posted
- 14 Aug 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 Pharmacokinetics and safety/tolerability between Fimasartan/Amlodipine/Hydrochlorothiazide and co administration of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: Treatment T, Drug: Treatment RPeriod 1(Treatment R) - Period 2(Treatment R) - Period 3(Treatment T) There will be a 14 washout of days between the each period. |
| Sequence B | Experimental | Drug: Treatment T, Drug: Treatment RPeriod 1(Treatment R) - Period 2(Treatment T) - Period 3(Treatment R) There will be a 14 washout of days between the each period. |
| Sequence C | Experimental | Drug: Treatment T, Drug: Treatment RPeriod 1(Treatment T) - Period 2(Treatment R) - Period 3(Treatment R) There will be a 14 washout of days between the each period. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- A healthy 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 |
|---|---|---|
| Treatment TAlso: FAHFixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide | Drug | Sequence A, Sequence B, Sequence C |
| Treatment RAlso: FA/HCo-administration of Fimasartan/Amlodipine and Hydrochlorothiazide | Drug | Sequence A, Sequence B, Sequence C |
Primary outcome
Cmax
Time frame: 0~144hours after Medication
Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma
1 secondary outcome
AUCinf
Time frame: 0~144hours 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 Jan 2019.
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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.
Kyung-sang Yu principal investigator
Seoul National University Hospital
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 Treatment T and Treatment R in people with Pharmacokinetics, 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 Jan 2019. 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: 0~144hours 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 Jan 2019.