HypertensionPhase 1NCT02397590
Study to Evaluate the Pharmacokinetic Interaction Between Fimasartan and Atorvastatin in Healthy Male Volunteers
A Phase 1 study testing Fimasartan and Atorvastatin 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/Atorvastatin combination tablet and coadministration of fimasartan and Atorvastatin 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 and Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Jun 2015
- 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 between 19.0 and 28.0 of ideal body weight (IBW)(kg) = {height (cm) - 100} * 0.9
Who cannot join
- 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
- Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- 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)]
- Participation in any other study within 2 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Six-sequence, Three-period, Multiple Dosing Study to Evaluate the Pharmacokinetic Interaction Between Fimasartan and Atorvastatin in Healthy Male Volunteers
A phase I clinical trial to compare the pharmacokinetics and safety of fimasartan/Atorvastatin combination tablet and coadministration of fimasartan and Atorvastatin in healthy male volunteers.
Read the detailed description
After subjects have signed informed consent voluntarily, they go through screening period for within 21 days.
Group 1 period 2 period 3 period A F A F+A B F F+A A C A F+A F D A F F+A E F+A F A F F+A A F
At each period taking Fimasartan, subjects of this Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times in each period).
At each period taking Atorvastatin, subjects of this Group have blood sampling 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hour after medication(12 times in each period).
At each period taking Fimasartan and Atorvastatin, subjects of this Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times in each period).
- Conditions
- Hypertension
- Being tested
- Fimasartan, Atorvastatin
- 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
AtorvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| A Group | Other | Fimasartan (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) Receives: Drug: Fimasartan; Drug: Atorvastatin |
| B Group | Other | Fimasartan (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days) Receives: Drug: Fimasartan; Drug: Atorvastatin |
| C Group | Other | Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days) Receives: Drug: Fimasartan; Drug: Atorvastatin |
| D Group | Other | Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) Receives: Drug: Fimasartan; Drug: Atorvastatin |
| E Group | Other | Fimasartan+Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days) → wash out (7days) → Atorvastatin (7 days) Receives: Drug: Fimasartan; Drug: Atorvastatin |
| F Group | Other | Fimasartan+Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days) Receives: Drug: Fimasartan; Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC tau,ss
Measured: Time Frame: 0~48 hour after medication
Cmax,ss
Measured: Time Frame: 0~48 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 posted25 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionJun 2015
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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397590
- Sponsor's protocol ID
- BR-FMS-CT-117
- Status last verified
- Mar 2015
- First submitted
- 16 Mar 2015
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Six-sequence, Three-period, Multiple Dosing Study to Evaluate the Pharmacokinetic Interaction Between Fimasartan and Atorvastatin in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02397590
- Acronym / sponsor ID
- BR-FMS-CT-117
- Conditions
- Hypertension
- Keywords
- Fimasartan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Mar 2015 (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/Atorvastatin combination tablet and coadministration of fimasartan and Atorvastatin in healthy male volunteers.
Detailed description
After subjects have signed informed consent voluntarily, they go through screening period for within 21 days.
Group 1 period 2 period 3 period A F A F+A B F F+A A C A F+A F D A F F+A E F+A F A F F+A A F
At each period taking Fimasartan, subjects of this Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times in each period).
At each period taking Atorvastatin, subjects of this Group have blood sampling 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hour after medication(12 times in each period).
At each period taking Fimasartan and Atorvastatin, subjects of this Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times in each period).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A Group | Other | Drug: Fimasartan, Drug: AtorvastatinFimasartan (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) |
| B Group | Other | Drug: Fimasartan, Drug: AtorvastatinFimasartan (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days) |
| C Group | Other | Drug: Fimasartan, Drug: AtorvastatinAtorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days) |
| D Group | Other | Drug: Fimasartan, Drug: AtorvastatinAtorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) |
| E Group | Other | Drug: Fimasartan, Drug: AtorvastatinFimasartan+Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days) → wash out (7days) → Atorvastatin (7 days) |
| F Group | Other | Drug: Fimasartan, Drug: AtorvastatinFimasartan+Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days) |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male subject, aged 19- 50 years at screening.
- Body weight between 19.0 and 28.0 of ideal body weight (IBW)(kg) = {height (cm) - 100} * 0.9
Key exclusion criteria (5 listed)
- 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
- Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- 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)]
- Participation in any other study within 2 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)
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 | A Group, B Group, C Group, D Group, E Group, F Group |
| Atorvastatin | Drug | A Group, B Group, C Group, D Group, E Group, F Group |
Primary outcome
AUC tau,ss
Time frame: Time Frame: 0~48 hour after medication
Cmax,ss
Time frame: Time Frame: 0~48 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 23 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Atorvastatin 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 2 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 23 Jul 2015. 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?
AUC tau,ss (time frame: Time Frame: 0~48 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 23 Jul 2015.