DyslipidemiaPhase 1NVP-1205NCT02029625
Compare the Pharmacokinetics of NVP-1205 and Coadministration of Rosuvastatin and Ezetimibe
A Phase 1 study testing NVP-1205 and rosuvastatin and ezetimibe in people with Dyslipidemia, run by NVP Healthcare at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the pharmacokinetics of NVP-1205 and coadministration of rosuvastatin and ezetimibe. 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
- Dyslipidemia
- What is being tested?
- NVP-1205 and rosuvastatin and ezetimibe
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to Mar 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 subjects age between 19 and 55 signed informed consent
Who cannot join
- subjects have a history of allergy reaction of this drug or other drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial to Compare the Pharmacokinetics and Safety of NVP-1205 and Coadministration of Rosuvastatin and Ezetimibe in Healthy Male Volunteers
The purpose of this study is to compare the pharmacokinetics of NVP-1205 and coadministration of rosuvastatin and ezetimibe.
Read the detailed description
rosuvastatin and ezetimibe(anti-dyslipidemia)
- Conditions
- Dyslipidemia
- Being tested
- NVP-1205, rosuvastatin and ezetimibe
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVP-1205Drug
Also called NVP-1205(rosuvastatin+ezetimibe)
rosuvastatin/ezetimibe fixed dose combination orally, once daily on Period 1 or Period 2
rosuvastatin and ezetimibeDrug
Also called Crestor and Ezetrol
coadministration of rosuvastatin and ezetimibe orally, once daily on Period 1 or Period 2
| Study group | Role | What they receive |
|---|---|---|
| NVP-1205 | Experimental | administration of NVP-1205(rosuvastatin+ezetimibe) Receives: Drug: NVP-1205 |
| rosuvastatin and ezetimibe | Active comparator | coadministration of rosuvastatin and ezetimibe Receives: Drug: rosuvastatin and ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast
Measured: 0-96hr
Secondary outcomes (1)
AUCinf
Measured: 0-96hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- NVP Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoon Yo Ran, M.D., Ph,D., Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029625
- Sponsor's protocol ID
- NVP-1205-01
- Acronym
- NVP-1205
- Status last verified
- Mar 2016
- First submitted
- 5 Jan 2014
- Last updated
- 25 Mar 2016
- 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 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Compare the Pharmacokinetics and Safety of NVP-1205 and Coadministration of Rosuvastatin and Ezetimibe in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02029625
- Acronym / sponsor ID
- NVP-1205 / NVP-1205-01
- Conditions
- Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- NVP HealthcareIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 8 Jan 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.
The purpose of this study is to compare the pharmacokinetics of NVP-1205 and coadministration of rosuvastatin and ezetimibe.
Detailed description
rosuvastatin and ezetimibe(anti-dyslipidemia)
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NVP-1205 | Experimental | Drug: NVP-1205administration of NVP-1205(rosuvastatin+ezetimibe) |
| rosuvastatin and ezetimibe | Active comparator | Drug: rosuvastatin and ezetimibecoadministration of rosuvastatin and ezetimibe |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male subjects age between 19 and 55 signed informed consent
Key exclusion criteria (1 listed)
- subjects have a history of allergy reaction of this drug or other drugs
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 |
|---|---|---|
| NVP-1205Also: NVP-1205(rosuvastatin+ezetimibe)rosuvastatin/ezetimibe fixed dose combination orally, once daily on Period 1 or Period 2 | Drug | NVP-1205 |
| rosuvastatin and ezetimibeAlso: Crestor and Ezetrolcoadministration of rosuvastatin and ezetimibe orally, once daily on Period 1 or Period 2 | Drug | rosuvastatin and ezetimibe |
Primary outcome
AUClast
Time frame: 0-96hr
1 secondary outcome
AUCinf
Time frame: 0-96hr
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 25 Mar 2016.
- 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.
Yoon Yo Ran, 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 NVP-1205 and rosuvastatin and ezetimibe in people with Dyslipidemia, run by NVP Healthcare 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 1 inclusion and 1 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 25 Mar 2016. 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: 0-96hr). 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 25 Mar 2016.