HealthyPhase 1NCT02380976
Phase 1 Clinical Trial of DW340 and DW330SR + DW1030 Co-administration in Healthy Male Volunteers
A Phase 1 study testing combination drug: DW330SR, DW1030 and DW340 in people with Healthy, run by Daewon Pharmaceutical Co., Ltd..
Trial summary
A randomized, open-label, single-dose, crossover Phase I Study to investigate the relative bioavailability of DW340 and DW330SR + DW1030 co-administration in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- combination drug: DW330SR, DW1030 and DW340
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age at screening visit only 20 healthy men over the age of 40 years or less
- Screening visit, BMI measurement is more than 19 kg/m2 who are below 27 kg/m2
- Screening vist, 90 mmHg ≤ SBP ≤ 140 mmHg, 50 mmHg ≤ DBP ≤ 90 mmHg
- Fully understand the purpose of trial, test drug and follow the instructions of the trial, Those who voluntarily written consent that ability and decision to participate during the entire period of the test
Who cannot join
- Those with a clinically significant history or character; Liver, kidney, digestive, respiratory, musculoskeletal, endocrine, neuropsychiatric, blood • tumor type, cardiovascular disease
- Those with Gastrointestinal diseases that may affect the absorption of the IND or history of surgery
- Those who have a clinically significant history of hypersensitivity to drug and food
- Those with genetic problems, such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- Within 60 days those taking the other clinical trial drug
- Within 30 days those who take the drug metabolizing enzyme induction and inhibition drugs or prescription drugs
Show all 13Show fewer
- Within 30 days those who take food abnormally, that may affect ADME of drug
- Within 60 days those who donate whole blood, within 30 days those who donate blood partially, receive transfusion
- Within 14 days those who take OTC drug
- Those who showing positive for drug abuse concerns in urine drug testing
- Those who drink excessive alcohol or have history of alcoholism
- Heavy smoker
- and so on
About this study
A randomized, open-label, single-dose, crossover Phase I Study to investigate the relative bioavailability of DW340 and DW330SR + DW1030 co-administration in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- combination drug: DW330SR, DW1030, DW340
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination drug: DW330SR, DW1030Drug
DW340Drug
| Study group | Role | What they receive |
|---|---|---|
| Test 1 | Experimental | First phase: DW330SR+DW1030 7 days after Second phase: DW340 Receives: Drug: combination drug: DW330SR, DW1030; Drug: DW340 |
| Test 2 | Experimental | First phase: DW340 7 days after Second phase: DW330SR+DW1030 Receives: Drug: combination drug: DW330SR, DW1030; Drug: DW340 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of DW330SR
Measured: 9 days
Cmax of DW340
Measured: 9 days
Cmax of DW1030
Measured: 9 days
AUClast of DW330SR
Measured: 9 days
AUClast of DW340
Measured: 9 days
AUClast of DW1030
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2015
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380976
- Sponsor's protocol ID
- DW340-1002
- Status last verified
- Oct 2016
- First submitted
- 24 Feb 2015
- Last updated
- 12 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial of DW340 and DW330SR + DW1030 Co-administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02380976
- Acronym / sponsor ID
- DW340-1002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Oct 2015 (actual)
- First posted
- 5 Mar 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.
A randomized, open-label, single-dose, crossover Phase I Study to investigate the relative bioavailability of DW340 and DW330SR + DW1030 co-administration 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 1 | Experimental | Drug: combination drug: DW330SR, DW1030, Drug: DW340First phase: DW330SR+DW1030 7 days after Second phase: DW340 |
| Test 2 | Experimental | Drug: combination drug: DW330SR, DW1030, Drug: DW340First phase: DW340 7 days after Second phase: DW330SR+DW1030 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age at screening visit only 20 healthy men over the age of 40 years or less
- Screening visit, BMI measurement is more than 19 kg/m2 who are below 27 kg/m2
- Screening vist, 90 mmHg ≤ SBP ≤ 140 mmHg, 50 mmHg ≤ DBP ≤ 90 mmHg
- Fully understand the purpose of trial, test drug and follow the instructions of the trial, Those who voluntarily written consent that ability and decision to participate during the entire period of the test
Key exclusion criteria (13 listed)
- Those with a clinically significant history or character; Liver, kidney, digestive, respiratory, musculoskeletal, endocrine, neuropsychiatric, blood • tumor type, cardiovascular disease
- Those with Gastrointestinal diseases that may affect the absorption of the IND or history of surgery
- Those who have a clinically significant history of hypersensitivity to drug and food
- Those with genetic problems, such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- Within 60 days those taking the other clinical trial drug
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 |
|---|---|---|
| combination drug: DW330SR, DW1030 | Drug | Test 1, Test 2 |
| DW340 | Drug | Test 1, Test 2 |
Primary outcome
Cmax of DW330SR
Time frame: 9 days
Cmax of DW340
Time frame: 9 days
Cmax of DW1030
Time frame: 9 days
AUClast of DW330SR
Time frame: 9 days
AUClast of DW340
Time frame: 9 days
AUClast of DW1030
Time frame: 9 days
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 12 Oct 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.
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 combination drug: DW330SR, DW1030 and DW340 in people with Healthy, run by Daewon 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 13 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 12 Oct 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?
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?
Cmax of DW330SR (time frame: 9 days). The study lists 6 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 12 Oct 2016.