Hypertension, HyperlipidemiaPhase 1NCT02995720
A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin
A Phase 1 study testing Fimasartan/Amlodipine combination drug, Rosuvastatin in people with Hypertension, Hyperlipidemia, run by Boryung Pharmaceutical Co., Ltd.
Trial summary
An open-label, randomized, single-dose, 2X3X3 partial replicate, crossover study to compare the pharmacokinetics and safety between a fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin in healthy male subjects. 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, Hyperlipidemia
- What is being tested?
- Fimasartan/Amlodipine combination drug, Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 26 Aug 2016to 30 May 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
- Healthy male subject, aged 19- 50 years
Who cannot join
- History of clinically significant hypersensitivity to study drug, any other drug
- Hypotension or hypertension
- Active liver disease
- History of gastrointestinal disease
- History of excessive alcohol abuse
- Participation in any other study within 3 months
About this study
Official title: An Open-label, Randomized, Single-dose, 2X3X3 Partial Replicate, Crossover Study to Compare the Pharmacokinetics and Safety Between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects
An open-label, randomized, single-dose, 2X3X3 partial replicate, crossover study to compare the pharmacokinetics and safety between a fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin in healthy male subjects.
- Conditions
- Hypertension, Hyperlipidemia
- Being tested
- Fimasartan/Amlodipine combination drug, Rosuvastatin
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fimasartan/Amlodipine combination drug, RosuvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | A fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin Receives: Drug: Fimasartan/Amlodipine combination drug, Rosuvastatin |
| 2 | Active comparator | Co-administration of Fimasartan/Amlodipine combination drug and Rosuvastatin Receives: Drug: Fimasartan/Amlodipine combination drug, Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (Maximum concentration of drug in plasma) of Fimasartan, Amlodipine and Rosuvastatin
Measured: 0~72 hour after medication
AUCt (Area Under the Curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine and Rosuvastatin
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 posted16 Dec 2016 (estimated)
- Study start26 Aug 2016
- Primary completion10 Nov 2016
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, HyperlipidemiaStudies 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995720
- Sponsor's protocol ID
- BR-FARC-CT-103
- Status last verified
- Aug 2017
- First submitted
- 1 Dec 2016
- Last updated
- 10 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, 2X3X3 Partial Replicate, Crossover Study to Compare the Pharmacokinetics and Safety Between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02995720
- Acronym / sponsor ID
- BR-FARC-CT-103
- Conditions
- Hypertension, Hyperlipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2016 (actual)
- Primary completion
- 10 Nov 2016 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 16 Dec 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.
An open-label, randomized, single-dose, 2X3X3 partial replicate, crossover study to compare the pharmacokinetics and safety between a fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fimasartan/Amlodipine combination drug, RosuvastatinA fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin |
| 2 | Active comparator | Drug: Fimasartan/Amlodipine combination drug, RosuvastatinCo-administration of Fimasartan/Amlodipine combination drug and Rosuvastatin |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male subject, aged 19- 50 years
Key exclusion criteria (6 listed)
- History of clinically significant hypersensitivity to study drug, any other drug
- Hypotension or hypertension
- Active liver disease
- History of gastrointestinal disease
- History of excessive alcohol abuse
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/Amlodipine combination drug, Rosuvastatin | Drug | 1, 2 |
Primary outcome
Cmax (Maximum concentration of drug in plasma) of Fimasartan, Amlodipine and Rosuvastatin
Time frame: 0~72 hour after medication
AUCt (Area Under the Curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine and Rosuvastatin
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 10 Aug 2017.
Related trials for Hypertension, Hyperlipidemia
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
Not yet recruitingEarly Phase 1
Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health (Healthy Heart - CKM)
Hypertension (HTN), Diabetes (DM)
Enrolling by invitation
ECHO for Diabetes and Multiple Chronic Conditions Study
Diabetes Mellitus, Chronic Disease
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fimasartan/Amlodipine combination drug, Rosuvastatin in people with Hypertension, Hyperlipidemia, 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 1 inclusion and 6 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 Aug 2017. 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 (Maximum concentration of drug in plasma) of Fimasartan, Amlodipine and Rosuvastatin (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 10 Aug 2017.