HealthyPhase 1NCT01415466
Pharmacokinetics and Drug Interaction Study Between Rosuvastatin and CS-866 in Healthy Male Volunteers
A Phase 1 study testing Cresto, Olmetec and Cresto, Olmetec in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and CS-866 in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cresto, Olmetec and Cresto, Olmetec
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Oct 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male volunteers aged 20 to 50 years
- A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
Who cannot join
- A subject who had any allergic history to any drug.
- A subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, genitourinary, psychology, ophthalmic, dermatology and gastrointestinal function or other significant diseases
- History or suspicion of current drug abuse
- A subject who had received treatment with below listed drug within specified period prior to the first dose of study medication
- Within 1 month: drug known CYP inducer or inhibitor
- Within 2 weeks: Prescribed or herbal medicine
Show all 10Show fewer
- Within 1 weeks: OTC medicine
- Within 2 days: Consumption of caffeine
- A subject who had participated in any other clinical study within the last 2 weeks
- A subject from whom over 400mL of blood was sampled(whole blood donation) within last 2 weeks or plasma/platelet donation within 1 month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Multiple-Dose, Cross-over Clinical Study to Investigate Pharmacokinetics and Drug-Drug Interaction Between Rosuvastatin and CS-866 in Healthy Male Volunteers
The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and CS-866 in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- Cresto, Olmetec, Cresto, Olmetec
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrestoDrug
tablet, 20mg
OlmetecDrug
tablet, 40mg
Cresto, OlmetecDrug
tablet, 20mg and 40mg
| Study group | Role | What they receive |
|---|---|---|
| R | Experimental | multiple dose of Rosuvastatin 20mg Receives: Drug: Cresto |
| O | Experimental | multiple dose of CS-866 40mg Receives: Drug: Olmetec |
| R+O | Experimental | multiple dose of the combination of Rosuvastatin 20mg and CS-866 40mg Receives: Drug: Cresto, Olmetec |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCtau
Measured: Multiple blood samples will be collected for 72 hours after last dosing in each of the periods.((in case of CS-866, for 48 hours)
Css,max
Measured: Multiple blood samples will be collected for 72 hours after last dosing in each of the periods.(in case of CS-866, for 48 hours)
Secondary outcomes (4)
AUCss,last
Measured: Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours)
AUCss,inf
Measured: Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours)
Css,min
Measured: Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours)
T1/2
Measured: Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2011
- Study completionOct 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 Daewoong Pharmaceutical Co. LTD.The 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
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yonsei University
- Responsible party
- Sponsor
- Investigators
- Kyungsoo Park, M.D., Ph.D., Principal investigator, YONSEI UNIVERSITY HEALTH SYSTEM (YUHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415466
- Sponsor's protocol ID
- DW_DWJ1276001
- Status last verified
- Apr 2012
- First submitted
- 9 Aug 2011
- Last updated
- 4 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Multiple-Dose, Cross-over Clinical Study to Investigate Pharmacokinetics and Drug-Drug Interaction Between Rosuvastatin and CS-866 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01415466
- Acronym / sponsor ID
- DW_DWJ1276001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Collaborators
- Yonsei University
- Study start
- Aug 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 12 Aug 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 the pharmacokinetics profile and drug-drug interaction between rosuvastatin and CS-866 in healthy male volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| R | Experimental | Drug: Crestomultiple dose of Rosuvastatin 20mg |
| O | Experimental | Drug: Olmetecmultiple dose of CS-866 40mg |
| R+O | Experimental | Drug: Cresto, Olmetecmultiple dose of the combination of Rosuvastatin 20mg and CS-866 40mg |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult male volunteers aged 20 to 50 years
- A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
Key exclusion criteria (10 listed)
- A subject who had any allergic history to any drug.
- A subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, genitourinary, psychology, ophthalmic, dermatology and gastrointestinal function or other significant diseases
- History or suspicion of current drug abuse
- A subject who had received treatment with below listed drug within specified period prior to the first dose of study medication
- A subject who had participated in any other clinical study within the last 2 weeks
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 |
|---|---|---|
| Crestotablet, 20mg | Drug | R |
| Olmetectablet, 40mg | Drug | O |
| Cresto, Olmetectablet, 20mg and 40mg | Drug | R+O |
Primary outcome
AUCtau
Time frame: Multiple blood samples will be collected for 72 hours after last dosing in each of the periods.((in case of CS-866, for 48 hours)
Css,max
Time frame: Multiple blood samples will be collected for 72 hours after last dosing in each of the periods.(in case of CS-866, for 48 hours)
4 secondary outcomes
AUCss,last
Time frame: Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours)
AUCss,inf
Time frame: Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours)
Css,min
Time frame: Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours)
T1/2
Time frame: Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours)
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 4 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.
Kyungsoo Park, M.D., Ph.D. principal investigator
YONSEI UNIVERSITY HEALTH SYSTEM (YUHS)
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 Cresto, Olmetec and Cresto, Olmetec in people with Healthy, run by Daewoong 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 10 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 4 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?
AUCtau (time frame: Multiple blood samples will be collected for 72 hours after last dosing in each of the periods.((in case of CS-866, for 48 hours)). 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 4 Apr 2012.