HypertensionPhase 1NCT02205151
To Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets
A Phase 1 study testing Fimasartan, Amlodipine and Fimasartan/Amlodipine combination in people with Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets 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
- Hypertension
- What is being tested?
- Fimasartan, Amlodipine and Fimasartan/Amlodipine combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Sep 2014
- 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
- Healthy male subject, aged 19- 50 years at screening.
- Body weight of ≥ 50 kg and within ± 20% of ideal body weight (IBW)(kg) = {height (cm) - 100} * 0.9
- Subjects must be able to listen to and understand the detailed statement of informed consent, and willing to decide to participate in the study, follow the study directions and provide written informed consent
Who cannot join
- History of gastrointestinal disease (i.g., Crohn's disease, active peptic ulcer) or resection operation that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy)
- History of clinically significant hypersensitivity to study drug, any other drug or additives (yellow no.4).
- Subject that is judged inappropriate for participating in the study based on physical examination
- The levels of ALT(Aspartate Transaminase), AST (Alanin Transaminase) or total bilirubin > 1.5 x the upper limit of normal or eGFR < 60 mL/min/1.73m (calculated by MDRD)
- Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- systolic ≥ 140 mmHg or ≤ 100 mmHg, diastolic ≥ 90 mmHg or ≤ 65 mmHg), measured after taking a rest for 5minutes
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- Take any other study's investigational products within 90 days prior to the first administration of study drug
- Donation of whole blood within 60 days prior to the first administration of study drug, or donation of any blood products within 30 days prior to the first administration of study drug
- Intake food like Grapefruit juice (*e.g., Grapefruit juice ≥ 1L /day) within 7 days prior to administration of study drug
- Use of any prescribed drugs or herbal remedies within 14 days, or use of any over-the-counter medication or vitamins within 7 days prior to the first administration of study drug
- Positive serologic tests (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)
- Subject that is judged inappropriate for participating in the study by an investigator, based any other reason
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic university St. Mary hospital
Seoul, 137-701
About this study
Official title: An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets in Healthy Male Volunteers
An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets in Healthy Male Volunteers
Read the detailed description
After subjects have signed informed consent voluntarily, they go through screening period for within 21 days.
As period I, subjects of A Group take fimasartan and amlodipine at 1st day and subjects of B Group take fimasartan/amlodipine combination at 1st day.
And then, after wash out for 14 days, as period II, subjects of A Group take fimasartan/amlodipine combination at 15th day and subjects of B Group take fimasartan and amlodipine at 15th day.
At each period, subjects of A Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36 times in total).
At each period, subjects of B Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36 times in total).
- Conditions
- Hypertension
- Being tested
- Fimasartan, Amlodipine, Fimasartan/Amlodipine combination
- Keywords
- Fimasartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FimasartanDrug
AmlodipineDrug
Fimasartan/Amlodipine combinationDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment AB | Other | Treatment A (1 day) → wash-out(14days) → Treatment B (1 day)
Treatment A : Fimasartanm and Amlodipine
Treatment B : Fimasartan/Amlodipine combination Receives: Drug: Fimasartan; Drug: Amlodipine; Drug: Fimasartan/Amlodipine combination |
| Treatment BA | Other | Treatment B (1 day) → wash-out(14days) → Treatment A (1 day)
Treatment A : Fimasartanm and Amlodipine
Treatment B : Fimasartan/Amlodipine combination Receives: Drug: Fimasartan; Drug: Amlodipine; Drug: Fimasartan/Amlodipine combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Cmax)
Measured: 0~144 hour after medication
(AUClast)
Measured: 0~144 hour after medication
Secondary outcomes (3)
(AUCinf)
Measured: 0~144 hour after medication
(tmax)
Measured: 0~144 hour after medication
(t1/2)
Measured: 0~144 hour after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionSep 2014
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.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyunghee university hospital A Drug Analytical Laboratory
- Responsible party
- Sponsor
- Investigators
- seunghoon han, M.D., Ph.D., Principal investigator, The Catholic university St. Mary hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205151
- Sponsor's protocol ID
- BR-FAC-CT-101
- Status last verified
- Jul 2014
- First submitted
- 29 Jul 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02205151
- Acronym / sponsor ID
- BR-FAC-CT-101
- Conditions
- Hypertension
- Keywords
- Fimasartan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Kyunghee university hospital A Drug Analytical Laboratory
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 31 Jul 2014 (estimated)
- 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.
An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets in Healthy Male Volunteers
Detailed description
After subjects have signed informed consent voluntarily, they go through screening period for within 21 days.
As period I, subjects of A Group take fimasartan and amlodipine at 1st day and subjects of B Group take fimasartan/amlodipine combination at 1st day.
And then, after wash out for 14 days, as period II, subjects of A Group take fimasartan/amlodipine combination at 15th day and subjects of B Group take fimasartan and amlodipine at 15th day.
At each period, subjects of A Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36 times in total).
At each period, subjects of B Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36 times in total).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment AB | Other | Drug: Fimasartan, Drug: Amlodipine, Drug: Fimasartan/Amlodipine combinationTreatment A (1 day) → wash-out(14days) → Treatment B (1 day) Treatment A : Fimasartanm and Amlodipine Treatment B : Fimasartan/Amlodipine combination |
| Treatment BA | Other | Drug: Fimasartan, Drug: Amlodipine, Drug: Fimasartan/Amlodipine combinationTreatment B (1 day) → wash-out(14days) → Treatment A (1 day) Treatment A : Fimasartanm and Amlodipine Treatment B : Fimasartan/Amlodipine combination |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subject, aged 19- 50 years at screening.
- Body weight of ≥ 50 kg and within ± 20% of ideal body weight (IBW)(kg) = {height (cm) - 100} * 0.9
- Subjects must be able to listen to and understand the detailed statement of informed consent, and willing to decide to participate in the study, follow the study directions and provide written informed consent
Key exclusion criteria (12 listed)
- History of gastrointestinal disease (i.g., Crohn's disease, active peptic ulcer) or resection operation that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy)
- History of clinically significant hypersensitivity to study drug, any other drug or additives (yellow no.4).
- Subject that is judged inappropriate for participating in the study based on physical examination
- The levels of ALT(Aspartate Transaminase), AST (Alanin Transaminase) or total bilirubin > 1.5 x the upper limit of normal or eGFR < 60 mL/min/1.73m (calculated by MDRD)
- Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
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 | Drug | Treatment AB, Treatment BA |
| Amlodipine | Drug | Treatment AB, Treatment BA |
| Fimasartan/Amlodipine combination | Drug | Treatment AB, Treatment BA |
Primary outcome
(Cmax)
Time frame: 0~144 hour after medication
(AUClast)
Time frame: 0~144 hour after medication
3 secondary outcomes
(AUCinf)
Time frame: 0~144 hour after medication
(tmax)
Time frame: 0~144 hour after medication
(t1/2)
Time frame: 0~144 hour 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 15 Oct 2014.
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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.
seunghoon han, M.D., Ph.D. principal investigator
The Catholic university St. Mary 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 Fimasartan, Amlodipine and Fimasartan/Amlodipine combination in people with Hypertension, 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 3 inclusion and 12 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 15 Oct 2014. 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: 0~144 hour after medication). 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 15 Oct 2014.