HealthyPhase 1NCT02089399
Pharmacokinetics and Drug Interaction Study Between Amlodipine,Olmesartan and Rosuvastatin in Healthy Adult Volunteers
A Phase 1 study testing Sevikar(amlodipne/olmesartan) and crestor(Rosuvastatin) 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 amlodipine, olmesartan and rosuvastatin in healthy adult volunteers. 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
- Healthy
- What is being tested?
- Sevikar(amlodipne/olmesartan) and crestor(Rosuvastatin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Jun 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 aged 19 - 55 years
- A body mass index in the range 19 - 27 kg/m2
- Willingness to participate during the entire study period
- Written informed consent after being fully informed about the study procedures
Who cannot join
- Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
- History of clinically significant drug hypersensitivity
- Use of medication within 7 days before the first dose
- Heavy drinker (>140 g/week)
- Whole blood donation during 60 days before the study
- Judged not eligible for study participation by investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, 2-Sequence, Multiple-Dose, Cross-Over Study to Investigate the Drug-Drug Interaction of Sevikar and Crestor in Healthy Adult Volunteers
The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between amlodipine, olmesartan and rosuvastatin in healthy adult volunteers.
- Conditions
- Healthy
- Being tested
- Sevikar(amlodipne/olmesartan), crestor(Rosuvastatin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevikar(amlodipne/olmesartan)Drug
Treatment AB
crestor(Rosuvastatin)Drug
Treatment AB/Treatment C
| Study group | Role | What they receive |
|---|---|---|
| Treatment AB | Experimental | S->S+C Receives: Drug: Sevikar(amlodipne/olmesartan); Drug: crestor(Rosuvastatin) |
| Treatment C | Experimental | C Receives: Drug: crestor(Rosuvastatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCtau
Measured: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
Css,max
Measured: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
Secondary outcomes (2)
Tss,max
Measured: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
Css,min
Measured: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2014
- Study completionJun 2014
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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089399
- Sponsor's protocol ID
- DW_DWJ1351001
- Status last verified
- Apr 2015
- First submitted
- 14 Mar 2014
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, 2-Sequence, Multiple-Dose, Cross-Over Study to Investigate the Drug-Drug Interaction of Sevikar and Crestor in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02089399
- Acronym / sponsor ID
- DW_DWJ1351001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Mar 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 evaluate the pharmacokinetics profile and drug-drug interaction between amlodipine, olmesartan and rosuvastatin in healthy adult volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment AB | Experimental | Drug: Sevikar(amlodipne/olmesartan), Drug: crestor(Rosuvastatin)S->S+C |
| Treatment C | Experimental | Drug: crestor(Rosuvastatin)C |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects aged 19 - 55 years
- A body mass index in the range 19 - 27 kg/m2
- Willingness to participate during the entire study period
- Written informed consent after being fully informed about the study procedures
Key exclusion criteria (6 listed)
- Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
- History of clinically significant drug hypersensitivity
- Use of medication within 7 days before the first dose
- Heavy drinker (>140 g/week)
- Whole blood donation during 60 days before the study
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 |
|---|---|---|
| Sevikar(amlodipne/olmesartan)Treatment AB | Drug | Treatment AB |
| crestor(Rosuvastatin)Treatment AB/Treatment C | Drug | Treatment AB, Treatment C |
Primary outcome
AUCtau
Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
Css,max
Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
2 secondary outcomes
Tss,max
Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
Css,min
Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
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 29 Apr 2015.
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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 Sevikar(amlodipne/olmesartan) and crestor(Rosuvastatin) 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 4 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 29 Apr 2015. 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 sample will be collected for 24 hours after last dosing in each of the treatment). 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 29 Apr 2015.