HealthyPhase 1NCT01447797
A Bioequivalence Study Comparing Irbesartan/Atorvastatin Combination Tablet With Coadministration of Irbesartan and Atorvastatin
A Phase 1 study testing HCP0912 / Irbesartan and Atorvastatin in people with Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of Irbesartan and Atorvastatin in combination as HCP0912 Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HCP0912 / Irbesartan and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to Dec 2011
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20 and 45
- Signed informed consent form
- weight : over 45kg and in the range of ±20% of IBW
Who cannot join
- Has a medical history of hypersensitivity to atorvastatin or irbesartan
- severe Hypotension
- Not eligible for subject in health examination within 28 days of IP administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose Open-label Comparative Pharmacokinetic Study to Assess the Pharmacokinetic Characteristics of Irbesartan and Atorvastatin Between Irbesartan/Atorvastatin Combination Tablet and Coadministration of Irbesartan and Atorvastatin Tablets in Healthy Male Subjects
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of Irbesartan and Atorvastatin in combination as HCP0912
- Conditions
- Healthy
- Being tested
- HCP0912 / Irbesartan and Atorvastatin
- Keywords
- Irbesartan, Atorvastatin, combination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCP0912 / Irbesartan and AtorvastatinDrug
Irbesartan and Atorvastatin combination tablet / coadministration of Irbesartan and Atorvastatin
| Study group | Role | What they receive |
|---|---|---|
| HCP0912 | Experimental | Irbesartan/Atorvastatin combination tablet Receives: Drug: HCP0912 / Irbesartan and Atorvastatin |
| Irbesartan and Atorvastatin | Active comparator | coadministration of irbesartan and atorvastatin Receives: Drug: HCP0912 / Irbesartan and Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of Irbesartan
Measured: 0-48 hrs
AUC of Atorvastatin and 2-hydroxy atorvastatin
Measured: 0-48 hrs
Cmax of Irbesartan
Measured: 0-48 hrs
Cmax of Atorvastatin and 2-hydroxy atorvastatin
Measured: 0-48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ji-Young Park, MD, PhD, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447797
- Sponsor's protocol ID
- HM-IBAT-104
- Status last verified
- Sep 2011
- First submitted
- 28 Sep 2011
- Last updated
- 3 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Open-label Comparative Pharmacokinetic Study to Assess the Pharmacokinetic Characteristics of Irbesartan and Atorvastatin Between Irbesartan/Atorvastatin Combination Tablet and Coadministration of Irbesartan and Atorvastatin Tablets in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01447797
- Acronym / sponsor ID
- HM-IBAT-104
- Conditions
- Healthy
- Keywords
- Irbesartan, Atorvastatin, combination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 Oct 2011 (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 pharmacokinetics and safety after oral administration of Irbesartan and Atorvastatin in combination as HCP0912
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCP0912 | Experimental | Drug: HCP0912 / Irbesartan and AtorvastatinIrbesartan/Atorvastatin combination tablet |
| Irbesartan and Atorvastatin | Active comparator | Drug: HCP0912 / Irbesartan and Atorvastatincoadministration of irbesartan and atorvastatin |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 20 and 45
- Signed informed consent form
- weight : over 45kg and in the range of ±20% of IBW
Key exclusion criteria (3 listed)
- Has a medical history of hypersensitivity to atorvastatin or irbesartan
- severe Hypotension
- Not eligible for subject in health examination within 28 days of IP administration
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 |
|---|---|---|
| HCP0912 / Irbesartan and AtorvastatinIrbesartan and Atorvastatin combination tablet / coadministration of Irbesartan and Atorvastatin | Drug | HCP0912, Irbesartan and Atorvastatin |
Primary outcome
AUC of Irbesartan
Time frame: 0-48 hrs
AUC of Atorvastatin and 2-hydroxy atorvastatin
Time frame: 0-48 hrs
Cmax of Irbesartan
Time frame: 0-48 hrs
Cmax of Atorvastatin and 2-hydroxy atorvastatin
Time frame: 0-48 hrs
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 3 Apr 2012.
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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.
Ji-Young Park, MD, PhD principal investigator
Korea University Anam 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 HCP0912 / Irbesartan and Atorvastatin in people with Healthy, run by Hanmi Pharmaceutical Company Limited 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 3 inclusion and 3 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 3 Apr 2012. 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 of Irbesartan (time frame: 0-48 hrs). The study lists 4 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 3 Apr 2012.