HypertensionPhase 1NCT02920047
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Amlodipine in Healthy Male Subjects
A Phase 1 study testing Fimasartan/Amlodipine and Fimasartan + Amlodipine in people with Hypertension, run by Boryung Pharmaceutical Co., Ltd.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics and safety when administrated Fimasartan/Amlodipine and when co-administrated Fimasartan and Amlodipine. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Jan 2017
- 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
- Male 19-50 years of age.
- Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening.
- Medically healthy with no clinically significant medical history.
- Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.
Who cannot join
- History or presence of clinically significant medical or psychiatric condition or disease.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Seated blood pressure is less than 100/65 mmHg or greater than 140/90 mmHg at screening.
- Plasma donation within a month prior to the first dose of study drug.
- Participation in another clinical trial within 3 months prior to the first dose of study drug(s).
About this study
Official title: A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between a Fixed Dose Combination of Fimasartan/Amlodipine and Co-administration of Fimasartan and Amlodipine in Healthy Male Volunteers
The purpose of this study is to evaluate the pharmacokinetics and safety when administrated Fimasartan/Amlodipine and when co-administrated Fimasartan and Amlodipine.
Read the detailed description
This is an open-label, randomized, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Amlodipine and co-administration of Fimasartan and Amlodipine.
- Conditions
- Hypertension
- Being tested
- Fimasartan/Amlodipine, Fimasartan + Amlodipine
- 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.
Fimasartan/AmlodipineDrug
Treatment B
Fimasartan + AmlodipineDrug
Treatment A
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B)
There will be a washout of 14 days between the each period. Receives: Drug: Fimasartan/Amlodipine; Drug: Fimasartan + Amlodipine |
| Sequence B | Experimental | Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A)
There will be a washout of 14 days between the each period. Receives: Drug: Fimasartan/Amlodipine; Drug: Fimasartan + Amlodipine |
| Sequency C | Experimental | Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A)
There will be a washout of 14 days between the each period. Receives: Drug: Fimasartan/Amlodipine; Drug: Fimasartan + Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax and AUClast of Fimasartan, Amlodipine
Measured: Time Frame: 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 posted30 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017
- Study completionJan 2017
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
- Primary purpose
- Other
- 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, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920047
- Sponsor's protocol ID
- BR-FAC-CT-102
- Status last verified
- Jan 2018
- First submitted
- 28 Sep 2016
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. 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 a Fixed Dose Combination of Fimasartan/Amlodipine and Co-administration of Fimasartan and Amlodipine in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02920047
- Acronym / sponsor ID
- BR-FAC-CT-102
- Conditions
- Hypertension
- Keywords
- Fimasartan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 30 Sep 2016 (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.
The purpose of this study is to evaluate the pharmacokinetics and safety when administrated Fimasartan/Amlodipine and when co-administrated Fimasartan and Amlodipine.
Detailed description
This is an open-label, randomized, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Amlodipine and co-administration of Fimasartan and Amlodipine.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: Fimasartan/Amlodipine, Drug: Fimasartan + AmlodipinePeriod 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B) There will be a washout of 14 days between the each period. |
| Sequence B | Experimental | Drug: Fimasartan/Amlodipine, Drug: Fimasartan + AmlodipinePeriod 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A) There will be a washout of 14 days between the each period. |
| Sequency C | Experimental | Drug: Fimasartan/Amlodipine, Drug: Fimasartan + AmlodipinePeriod 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A) There will be a washout of 14 days between the each period. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male 19-50 years of age.
- Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening.
- Medically healthy with no clinically significant medical history.
- Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.
Key exclusion criteria (5 listed)
- History or presence of clinically significant medical or psychiatric condition or disease.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Seated blood pressure is less than 100/65 mmHg or greater than 140/90 mmHg at screening.
- Plasma donation within a month prior to the first dose of study drug.
- Participation in another clinical trial within 3 months prior to the first dose of study drug(s).
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/AmlodipineTreatment B | Drug | Sequence A, Sequence B, Sequency C |
| Fimasartan + AmlodipineTreatment A | Drug | Sequence A, Sequence B, Sequency C |
Primary outcome
Cmax and AUClast of Fimasartan, Amlodipine
Time frame: 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 9 Jan 2018.
- 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.
Kyung-Sang Yu, PhD principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fimasartan/Amlodipine and Fimasartan + Amlodipine in people with Hypertension, run by Boryung Pharmaceutical Co., Ltd.
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 5 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 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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 and AUClast of Fimasartan, Amlodipine (time frame: Time Frame: 0~144 hour 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 9 Jan 2018.