HypertensionPhase 1NCT02205190
to Compare the Pharmacokinetics and Safety of Fimasartan/Rosuvastatin Combination Tablet and Coadministration of Fimasartan and Rosuvastatin
A Phase 1 study testing Fimasartan, Rosuvastatin and Fimasartan/Rosuvastatin combination in people with Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
A phase I clinical trial to compare the pharmacokinetics and safety of fimasartan/rosuvastatin combination tablet and coadministration of fimasartan and rosuvastatin in healthy male volunteers Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Fimasartan, Rosuvastatin and Fimasartan/Rosuvastatin combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subject, aged 19- 55 years at screening.
- Body weight of ≥ 50 kg and within ± 20% of ideal body weight (IBW)(kg) = {height (cm) - 100} * 0.9
- No abnormal symptom or sign, based on medical history and physical examination, with no congenital or chronic disease that requires treatment
- Subject that is considered appropriate for participating in the study by an investigator, based on clinical laboratory test (serology, hematology, clinical chemistry, urinalysis) and ECG, performed within 3 weeks prior to administration of study drug
- 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 clinically significant hypersensitivity to study drug, any other drug or additives (yellow no.5).
- History of any illness that may affect the absorption, distribution, metabolism or excretion (hepatobiliary, renal, cardiovascular, endocrine (e.g., hypothyroidism), respiratory, gastrointestinal, hemato-oncology, central nervous system, psychiatric and musculoskeletal system)
- Hypotension (systolic ≤ 100 mmHg or diastolic ≤ 65 mmHg) or hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg), measured at screening
- Active liver disease, or the levels of ALT(Aspartate Transaminase), AST (Alanin Transaminase) or total bilirubin > 1.5 x the upper limit of normal
- Creatinine clearance < 60 mL/min (calculated by Cockcroft-Gault formula using serum creatinine)
- Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
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- 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 major injury, surgical operation, or suspected symptom of acute illness (severe infection, trauma, diarrhea or vomiting) within 4 weeks prior to the first administration of study drug
- History of excessive alcohol abuse (>21 units/week, 1 unit=10g=12.5mL of pure alcohol), or subjects who cannot abstain from drinking for at least 3 days prior to the start of this study and throughout the study period, or excessive smoking (>10 cigarettes/day)
- Use of any prescribed drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to the first administration of study drug, and this will affect this study or the safety of the subjects in the opinion of the investigator
- Participation in any other study within 3 months prior to the first administration of study drug (The finish time of previous study is the day of the last administration of study drug)
- Donation of whole blood within 2 months prior to the first administration of study drug, or donation of any blood products within 1 month prior to the first administration of study drug
- Abnormal diet that may affect absorption, distribution, metabolism and excretion of drugs (*e.g., Grapefruit juice ≥ 1L /day within 7 days prior to 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 on clinical laboratory test (serology, hematology, clinical chemistry, urinalysis) or any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of Fimasartan/Rosuvastatin Combination Tablet and Coadministration of Fimasartan and Rosuvastatin in Healthy Male Volunteers
A phase I clinical trial to compare the pharmacokinetics and safety of fimasartan/rosuvastatin combination tablet and coadministration of fimasartan and rosuvastatin 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 1 Group take fimasartan and rosuvastatin at 1st day and subjects of 2 Group take fimasartan/rosuvastatin combination at 1st day.
And then, after wash out for 7 days, as period II, subjects of 1 Group take fimasartan/rosuvastatin combination at 8th day and subjects of 2 Group take fimasartan and rosuvastatin at 8th day.
At each period, subjects of 1 Group have blood sampling 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hour after medication(17 times in each period, 34 times in total).
At each period, subjects of 2 Group have blood sampling 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hour after medication(17 times in each period, 34 times in total).
- Conditions
- Hypertension
- Being tested
- Fimasartan, Rosuvastatin, Fimasartan/Rosuvastatin 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
RosuvastatinDrug
Fimasartan/Rosuvastatin combinationDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment AB | Other | Treatment A (1 day) → wash-out(7days) → Treatment B (1 day)
Treatment A : Fimasartan and Rosuvastatin
Treatment B : Fimasartan/Rosuvastatin combination Receives: Drug: Fimasartan; Drug: Rosuvastatin; Drug: Fimasartan/Rosuvastatin combination |
| Treatment BA | Other | Treatment B (1 day) → wash-out(7days) → Treatment A (1 day)
Treatment A : Fimasartan and Rosuvastatin
Treatment B : Fimasartan/Rosuvastatin combination Receives: Drug: Fimasartan; Drug: Rosuvastatin; Drug: Fimasartan/Rosuvastatin combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
(AUClast)
Measured: 0~72 hour after medication
(Cmax)
Measured: 0~72 hour after medication
Secondary outcomes (3)
(AUCinf)
Measured: 0~72 hour after medication
(tmax)
Measured: 0~72 hour after medication
(t1/2)
Measured: 0~72 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyungpook National University Hospital
- Responsible party
- Sponsor
- Investigators
- youngran yoon, M.D., Ph.D., Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205190
- Sponsor's protocol ID
- BR-FRC-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
- A Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of Fimasartan/Rosuvastatin Combination Tablet and Coadministration of Fimasartan and Rosuvastatin in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02205190
- Acronym / sponsor ID
- BR-FRC-CT-101
- Conditions
- Hypertension
- Keywords
- Fimasartan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Kyungpook National University Hospital
- 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.
A phase I clinical trial to compare the pharmacokinetics and safety of fimasartan/rosuvastatin combination tablet and coadministration of fimasartan and rosuvastatin 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 1 Group take fimasartan and rosuvastatin at 1st day and subjects of 2 Group take fimasartan/rosuvastatin combination at 1st day.
And then, after wash out for 7 days, as period II, subjects of 1 Group take fimasartan/rosuvastatin combination at 8th day and subjects of 2 Group take fimasartan and rosuvastatin at 8th day.
At each period, subjects of 1 Group have blood sampling 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hour after medication(17 times in each period, 34 times in total).
At each period, subjects of 2 Group have blood sampling 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hour after medication(17 times in each period, 34 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: Rosuvastatin, Drug: Fimasartan/Rosuvastatin combinationTreatment A (1 day) → wash-out(7days) → Treatment B (1 day) Treatment A : Fimasartan and Rosuvastatin Treatment B : Fimasartan/Rosuvastatin combination |
| Treatment BA | Other | Drug: Fimasartan, Drug: Rosuvastatin, Drug: Fimasartan/Rosuvastatin combinationTreatment B (1 day) → wash-out(7days) → Treatment A (1 day) Treatment A : Fimasartan and Rosuvastatin Treatment B : Fimasartan/Rosuvastatin combination |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subject, aged 19- 55 years at screening.
- Body weight of ≥ 50 kg and within ± 20% of ideal body weight (IBW)(kg) = {height (cm) - 100} * 0.9
- No abnormal symptom or sign, based on medical history and physical examination, with no congenital or chronic disease that requires treatment
- Subject that is considered appropriate for participating in the study by an investigator, based on clinical laboratory test (serology, hematology, clinical chemistry, urinalysis) and ECG, performed within 3 weeks prior to administration of study drug
- 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 (15 listed)
- History of clinically significant hypersensitivity to study drug, any other drug or additives (yellow no.5).
- History of any illness that may affect the absorption, distribution, metabolism or excretion (hepatobiliary, renal, cardiovascular, endocrine (e.g., hypothyroidism), respiratory, gastrointestinal, hemato-oncology, central nervous system, psychiatric and musculoskeletal system)
- Hypotension (systolic ≤ 100 mmHg or diastolic ≤ 65 mmHg) or hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg), measured at screening
- Active liver disease, or the levels of ALT(Aspartate Transaminase), AST (Alanin Transaminase) or total bilirubin > 1.5 x the upper limit of normal
- Creatinine clearance < 60 mL/min (calculated by Cockcroft-Gault formula using serum creatinine)
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 |
| Rosuvastatin | Drug | Treatment AB, Treatment BA |
| Fimasartan/Rosuvastatin combination | Drug | Treatment AB, Treatment BA |
Primary outcome
(AUClast)
Time frame: 0~72 hour after medication
(Cmax)
Time frame: 0~72 hour after medication
3 secondary outcomes
(AUCinf)
Time frame: 0~72 hour after medication
(tmax)
Time frame: 0~72 hour after medication
(t1/2)
Time frame: 0~72 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.
youngran yoon, M.D., Ph.D. principal investigator
Kyungpook 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 Fimasartan, Rosuvastatin and Fimasartan/Rosuvastatin 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 5 inclusion and 15 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?
(AUClast) (time frame: 0~72 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.