HealthyPhase 1NCT02665832
Study of DWJ1351 in Healthy Male Volunteers
A Phase 1 study testing DWJ1351 and Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) in people with Healthy, run by Daewoong Pharmaceutical Co. LTD..
Trial summary
The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DWJ1351 and Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 2016
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male subjects aged 19 to 50 years
- Subjects whose body weight ≥ 55 kg and Body Mass Index(BMI) ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2
- Subject who was judged to be healthy and suitable for the participation by the investigator based on screening test results
- Subject who provided written informed consent to participate in this study
Who cannot join
- Subject who had a severe allergy or allergic reactions to the amlodipine, olmesartan, rosuvastatin or related drugs
- Subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, digestive system, reproductive system, neurology, psychology, ophthalmic and skin disease
- Subjects who had a serious clinical illness that can impact fate of drugs absorption
- Subject who shows vital signs with the number of systolic blood pressure of ≥150 mmHg or ≤100 mmHg, and the number of diastolic blood pressure of ≥100mmHg or ≤66mmHg
- Subject who have experienced drug abuse
- Subject who donates his blood (whole blood donation within last 2 months or plasma donation within last 1 month)
- Subject who has taken other clinical or licensed medication from another clinical trial within an 3-month period prior to the first administration of the study medication
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Open-label, Single-Dose, 2-Way Cross-over Study To Compare the Safety and Pharmacokinetic Characteristics of Combination of Amlodipine, Olmesartan and Rosuvastatin and DWJ1351 in Healthy Male Volunteers
The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers
- Conditions
- Healthy
- Being tested
- DWJ1351, Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWJ1351Drug
Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)Drug
| Study group | Role | What they receive |
|---|---|---|
| AB | Experimental | Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) followed by DWJ1351 Receives: Drug: DWJ1351; Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) |
| BA | Experimental | DWJ1351 followed by Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) Receives: Drug: DWJ1351; Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Measured: 0 - 144 hr
Cmax
Measured: 0 - 144 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (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.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
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
- NCT02665832
- Sponsor's protocol ID
- DW_DWJ1351002
- Status last verified
- Jan 2016
- First submitted
- 20 Jan 2016
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-Dose, 2-Way Cross-over Study To Compare the Safety and Pharmacokinetic Characteristics of Combination of Amlodipine, Olmesartan and Rosuvastatin and DWJ1351 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02665832
- Acronym / sponsor ID
- DW_DWJ1351002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 28 Jan 2016 (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 safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AB | Experimental | Drug: DWJ1351, Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) followed by DWJ1351 |
| BA | Experimental | Drug: DWJ1351, Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)DWJ1351 followed by Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult male subjects aged 19 to 50 years
- Subjects whose body weight ≥ 55 kg and Body Mass Index(BMI) ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2
- Subject who was judged to be healthy and suitable for the participation by the investigator based on screening test results
- Subject who provided written informed consent to participate in this study
Key exclusion criteria (7 listed)
- Subject who had a severe allergy or allergic reactions to the amlodipine, olmesartan, rosuvastatin or related drugs
- Subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, digestive system, reproductive system, neurology, psychology, ophthalmic and skin disease
- Subjects who had a serious clinical illness that can impact fate of drugs absorption
- Subject who shows vital signs with the number of systolic blood pressure of ≥150 mmHg or ≤100 mmHg, and the number of diastolic blood pressure of ≥100mmHg or ≤66mmHg
- Subject who have experienced drug abuse
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 |
|---|---|---|
| DWJ1351 | Drug | AB, BA |
| Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) | Drug | AB, BA |
Primary outcome
AUC
Time frame: 0 - 144 hr
Cmax
Time frame: 0 - 144 hr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DWJ1351 and Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) 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 4 inclusion and 7 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 Jan 2016. 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?
Contact Sang-Joon Kim (+82 550 8708, sjkim050@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (time frame: 0 - 144 hr). 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 Jan 2016.