HealthyPhase 1NCT02947139
Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers
A Phase 1 study testing Co-administration of DWC20155/DWC20156 and DWC20161 in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
A randomized, open label, crossover study to explore drug-drug interactions between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Co-administration of DWC20155/DWC20156 and DWC20161
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Sep 2016to 2 Nov 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Accepts healthy volunteers
Who cannot join
- Who has allergy to investigational product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Crossover Study to Explore Drug-drug Interaction Between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers
A randomized, open label, crossover study to explore drug-drug interactions between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers
- Conditions
- Healthy
- Being tested
- Co-administration of DWC20155/DWC20156, DWC20161
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-administration of DWC20155/DWC20156Drug
DWC20161Drug
| Study group | Role | What they receive |
|---|---|---|
| Study effect of DWC20161 on DWC20155/DWC20156 PK | Experimental | To study effect of DWC20161 on DWC20155/DWC20156 PK Receives: Drug: Co-administration of DWC20155/DWC20156; Drug: DWC20161 |
| Study effect of DWC20155/DWC20156 on DWC20161 PK | Experimental | To study effect of DWC20155/DWC20156 on DWC20161 PK Receives: Drug: Co-administration of DWC20155/DWC20156; Drug: DWC20161 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Measured: 0~24 hours
Area under the plasma concentration versus time curve (AUC)
Measured: 0~24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start29 Sep 2016
- Primary completion24 Oct 2016
- Study completion2 Nov 2016
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
- 53 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
- NCT02947139
- Sponsor's protocol ID
- DW_DWJ1366003
- Status last verified
- Feb 2017
- First submitted
- 26 Oct 2016
- Last updated
- 16 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Crossover Study to Explore Drug-drug Interaction Between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02947139
- Acronym / sponsor ID
- DW_DWJ1366003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2016 (actual)
- Primary completion
- 24 Oct 2016 (actual)
- Study completion
- 2 Nov 2016 (actual)
- First posted
- 27 Oct 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.
A randomized, open label, crossover study to explore drug-drug interactions between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study effect of DWC20161 on DWC20155/DWC20156 PK | Experimental | Drug: Co-administration of DWC20155/DWC20156, Drug: DWC20161To study effect of DWC20161 on DWC20155/DWC20156 PK |
| Study effect of DWC20155/DWC20156 on DWC20161 PK | Experimental | Drug: Co-administration of DWC20155/DWC20156, Drug: DWC20161To study effect of DWC20155/DWC20156 on DWC20161 PK |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Accepts healthy volunteers
Key exclusion criteria (1 listed)
- Who has allergy to investigational product
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 |
|---|---|---|
| Co-administration of DWC20155/DWC20156 | Drug | Study effect of DWC20155/DWC20156 on DWC20161 PK, Study effect of DWC20161 on DWC20155/DWC20156 PK |
| DWC20161 | Drug | Study effect of DWC20155/DWC20156 on DWC20161 PK, Study effect of DWC20161 on DWC20155/DWC20156 PK |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 0~24 hours
Area under the plasma concentration versus time curve (AUC)
Time frame: 0~24 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 16 Feb 2017.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 Co-administration of DWC20155/DWC20156 and DWC20161 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 1 inclusion and 1 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 16 Feb 2017. 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?
Peak Plasma Concentration (Cmax) (time frame: 0~24 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 16 Feb 2017.