Hypertension, HyperlipidemiaPhase 1NCT02994745
A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Atorvastatin in Healthy Male Volunteers.
A Phase 1 study testing Fimasartan, Atorvastatin in people with Hypertension, Hyperlipidemia, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability 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, Hyperlipidemia
- What is being tested?
- Fimasartan, Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Dec 2016to Aug 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
- A Healthy male aged 19-50 years
- Body weight is over 55kg and BMI 18 ~ 27(kg/m2).
- A subject provide written informed consent which he voluntarily confirms willingness to participate in a study, having been informed of the full details of the study and comply with the protocol.
- A subject who is eligible according to investigator's assessment
Who cannot join
- History or presence of clinically significant medical or psychiatric condition or disease.
- History of gastrointestinal disease and resection
- Hypersensitivity to ingredient of investigational product(IP) and other medication, food.
- Genetic Problem such as Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption.
- A subject who take a drug that inhibit or induce significantly Drug-Metabolizing Enzyme within 1months.
- Positive results for serum examination(HIV, B and C viral test, Syphilis).
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- Seated BP is less than 100/65 mmHg or greater than 140/90 mmHg at screening.
- Participation in any other study within 3months.
- History of whole blood donation within 2months and Apheresis 2 weeks.
Trial locations and contacts
1 site in 1 country.
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 120mg/Atorvastatin 40mg and Co-administration of Fimasartan 120mg and Atorvastatin 40mg in Healthy Male Volunteers.
The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of Fimasartan and Atorvastatin in Healthy Male volunteers.
Read the detailed description
This is a randomized, open-label, single dose, 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/Atorvastatin and co-administration of Fimasartan and Atorvastatin.
- Conditions
- Hypertension, Hyperlipidemia
- Being tested
- Fimasartan, Atorvastatin
- 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, AtorvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| A fixed dose combination group | Experimental | A fixed dose combination of Fimasartan/Atorvastatin Receives: Drug: Fimasartan, Atorvastatin |
| Co-administration group | Active comparator | Co-administration of Fimasartan and Atorvastatin Receives: Drug: Fimasartan, Atorvastatin |
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, Atorvastatin
Measured: 0~48 hours after medication
AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Fimasartan, Atorvastatin
Measured: 0~48 hours 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 start23 Dec 2016
- Primary completion21 Feb 2017
- Study completionAug 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
- NCT02994745
- Sponsor's protocol ID
- BR-FAVC-CT-102
- Status last verified
- Jan 2018
- First submitted
- 1 Dec 2016
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 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 120mg/Atorvastatin 40mg and Co-administration of Fimasartan 120mg and Atorvastatin 40mg in Healthy Male Volunteers.
- ClinicalTrials.gov ID
- NCT02994745
- Acronym / sponsor ID
- BR-FAVC-CT-102
- 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
- 23 Dec 2016 (actual)
- Primary completion
- 21 Feb 2017 (actual)
- Study completion
- Aug 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.
The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of Fimasartan and Atorvastatin in Healthy Male volunteers.
Detailed description
This is a randomized, open-label, single dose, 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/Atorvastatin and co-administration of Fimasartan and Atorvastatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A fixed dose combination group | Experimental | Drug: Fimasartan, AtorvastatinA fixed dose combination of Fimasartan/Atorvastatin |
| Co-administration group | Active comparator | Drug: Fimasartan, AtorvastatinCo-administration of Fimasartan and Atorvastatin |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- A Healthy male aged 19-50 years
- Body weight is over 55kg and BMI 18 ~ 27(kg/m2).
- A subject provide written informed consent which he voluntarily confirms willingness to participate in a study, having been informed of the full details of the study and comply with the protocol.
- A subject who is eligible according to investigator's assessment
Key exclusion criteria (9 listed)
- History or presence of clinically significant medical or psychiatric condition or disease.
- History of gastrointestinal disease and resection
- Hypersensitivity to ingredient of investigational product(IP) and other medication, food.
- Genetic Problem such as Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption.
- A subject who take a drug that inhibit or induce significantly Drug-Metabolizing Enzyme within 1months.
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, Atorvastatin | Drug | A fixed dose combination group, Co-administration group |
Primary outcome
Cmax(Maximum concentration of drug in plasma) of Fimasartan, Atorvastatin
Time frame: 0~48 hours after medication
AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Fimasartan, Atorvastatin
Time frame: 0~48 hours 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 18 Jan 2018.
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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, Atorvastatin in people with Hypertension, Hyperlipidemia, 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 4 inclusion and 9 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 18 Jan 2018. 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(Maximum concentration of drug in plasma) of Fimasartan, Atorvastatin (time frame: 0~48 hours 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 18 Jan 2018.