HealthyPhase 1NCT02561884
A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study on a Olostar Tab Versus Two Co-administered Reference Products Olmesartan Medoxomil and Rosuvastatin Calcium in Healthy Volunteers
A Phase 1 study testing Olostar Tab. and Co-administration of Olmetec and Crestor in people with Healthy, run by Daewoong Pharmaceutical Co. LTD..
Trial summary
To demonstrate the bioequivalence of a Olostar Tab versus two co-administered reference IMPs Olmetec and Crestor. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Olostar Tab. and Co-administration of Olmetec and Crestor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Oct 2015
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI ≥ 18.5 and ≤ 30.0 kg/m2.
- No clinically significant findings in a 12-lead electrocardiogram (ECG)
- Age 18-60 years at screening
Who cannot join
- History of severe allergy or allergic reactions to the IMPs or related drugs
- History of serious clinical illness that can impact fate of drugs including major surgery
About this study
To demonstrate the bioequivalence of a Olostar Tab versus two co-administered reference IMPs Olmetec and Crestor.
- Conditions
- Healthy
- Being tested
- Olostar Tab., Co-administration of Olmetec and Crestor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olostar Tab.Drug
Co-administration of Olmetec and CrestorDrug
| Study group | Role | What they receive |
|---|---|---|
| AB | Experimental | Olostar Tab. followed by Olmetec and Crestor Receives: Drug: Olostar Tab.; Drug: Co-administration of Olmetec and Crestor |
| BA | Experimental | Olmetec and Crestor followed by Olostar Tab. Receives: Drug: Olostar Tab.; Drug: Co-administration of Olmetec and Crestor |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Measured: 0~72hr
Cmax
Measured: 0~72hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
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.
- 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
- 58 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
- NCT02561884
- Sponsor's protocol ID
- DW_DWJ1276006
- Status last verified
- Sep 2015
- First submitted
- 24 Sep 2015
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study on a Olostar Tab Versus Two Co-administered Reference Products Olmesartan Medoxomil and Rosuvastatin Calcium in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02561884
- Acronym / sponsor ID
- DW_DWJ1276006
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 28 Sep 2015 (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.
To demonstrate the bioequivalence of a Olostar Tab versus two co-administered reference IMPs Olmetec and Crestor.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AB | Experimental | Drug: Olostar Tab., Drug: Co-administration of Olmetec and CrestorOlostar Tab. followed by Olmetec and Crestor |
| BA | Experimental | Drug: Olostar Tab., Drug: Co-administration of Olmetec and CrestorOlmetec and Crestor followed by Olostar Tab. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI ≥ 18.5 and ≤ 30.0 kg/m2.
- No clinically significant findings in a 12-lead electrocardiogram (ECG)
- Age 18-60 years at screening
Key exclusion criteria (2 listed)
- History of severe allergy or allergic reactions to the IMPs or related drugs
- History of serious clinical illness that can impact fate of drugs including major surgery
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 |
|---|---|---|
| Olostar Tab. | Drug | AB, BA |
| Co-administration of Olmetec and Crestor | Drug | AB, BA |
Primary outcome
AUC
Time frame: 0~72hr
Cmax
Time frame: 0~72hr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olostar Tab. and Co-administration of Olmetec and Crestor in people with Healthy, run by Daewoong Pharmaceutical Co. LTD..
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 2 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: status not confirmed, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 (time frame: 0~72hr). 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 28 Sep 2015.