HealthyPhase 1NCT03753477
Clinical Trial to Investigate the Efficacy and Safety of DWJ1351
A Phase 1 study testing DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) and Sevikar and Crestor 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 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(FDC Amlodipine/Olmesartan/Rosuvastatin) and Sevikar and Crestor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Dec 2017to 1 Feb 2018
- 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
- Subject who provided written informed consent to participate in this study
- 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
Who cannot join
- Subject who had a severe allergy or allergic reactions to the amlodipine, olmesartan, rosuvastatin or related drugs
- 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 >140 mmHg or <100 mmHg, and the number of diastolic blood pressure of >90mmHg or <65mmHg
- 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
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, 2X2 Crossover Study to Compare the Pharmacokinetics and Safety Between DWJ1351 and Co-administration of Amlodipine/Olmesartan and Rosuvastatin in Healthy Male Subjects
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 the detailed description
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(FDC Amlodipine/Olmesartan/Rosuvastatin), Sevikar and Crestor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)Drug
Also called DWJ1351
DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) X 1 tablet followed by Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet (after washout period)
Sevikar and CrestorDrug
Also called Amlodipine/Olmesartan and Rosuvastatin
Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet followed by FDC Amlodipine/Olmesartan/Rosuvastatin X 1 tablet (after washout period)
| Study group | Role | What they receive |
|---|---|---|
| Test Drug | Experimental | DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) Receives: Drug: DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) |
| Reference Drug | Active comparator | Sevikar and Crestor Receives: Drug: Sevikar and Crestor |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
AUC
Measured: [ Time Frame: 0 - 72 hours ]
Cmax
Cmax
Measured: [ Time Frame: 0 - 72 hours ]
Secondary outcomes (5)
AUCinf
AUCinf
Measured: [ Time Frame: 0 - 72 hours ]
Tmax
Tmax
Measured: [ Time Frame: 0 - 72 hours ]
t1/2β
t1/2β
Measured: [ Time Frame: 0 - 72 hours ]
CL/F
CL/F
Measured: [ Time Frame: 0 - 72 hours ]
Vdss/F
Vdss/F
Measured: [ Time Frame: 0 - 72 hours ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start22 Dec 2017
- Primary completion26 Jan 2018
- Study completion1 Feb 2018
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JG Shin, Ph.D, Principal investigator, Busan Paik Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753477
- Sponsor's protocol ID
- DW_DWJ1351004
- Status last verified
- Nov 2018
- First submitted
- 14 Feb 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, 2X2 Crossover Study to Compare the Pharmacokinetics and Safety Between DWJ1351 and Co-administration of Amlodipine/Olmesartan and Rosuvastatin in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03753477
- Acronym / sponsor ID
- DW_DWJ1351004
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 27 Nov 2018 (actual)
- 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
Detailed description
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Drug | Experimental | Drug: DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) |
| Reference Drug | Active comparator | Drug: Sevikar and CrestorSevikar and Crestor |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject who provided written informed consent to participate in this study
- 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
Key exclusion criteria (6 listed)
- Subject who had a severe allergy or allergic reactions to the amlodipine, olmesartan, rosuvastatin or related drugs
- 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 >140 mmHg or <100 mmHg, and the number of diastolic blood pressure of >90mmHg or <65mmHg
- 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)
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(FDC Amlodipine/Olmesartan/Rosuvastatin)Also: DWJ1351DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) X 1 tablet followed by Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet (after washout period) | Drug | Test Drug |
| Sevikar and CrestorAlso: Amlodipine/Olmesartan and RosuvastatinSevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet followed by FDC Amlodipine/Olmesartan/Rosuvastatin X 1 tablet (after washout period) | Drug | Reference Drug |
Primary outcome
AUC
Time frame: [ Time Frame: 0 - 72 hours ]
AUC
Cmax
Time frame: [ Time Frame: 0 - 72 hours ]
Cmax
5 secondary outcomes
AUCinf
Time frame: [ Time Frame: 0 - 72 hours ]
Tmax
Time frame: [ Time Frame: 0 - 72 hours ]
t1/2β
Time frame: [ Time Frame: 0 - 72 hours ]
CL/F
Time frame: [ Time Frame: 0 - 72 hours ]
Vdss/F
Time frame: [ Time Frame: 0 - 72 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 28 Nov 2018.
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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.
JG Shin, Ph.D principal investigator
Busan Paik 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 DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) and Sevikar and Crestor 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 28 Nov 2018. 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 (time frame: [ Time Frame: 0 - 72 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 28 Nov 2018.