HealthyPhase 1DW0919-1003NCT01606059
Phase 1 Study of DW-0919 & DW-0920 in Healthy Male Volunteers Under Fasting Condition
A Phase 1 study testing DW-0920 and DW-0919 in people with Healthy, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate safety and pharmacokinetics of DW-0919 and DW-0920 in healthy male volunteers under fasting condition. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DW-0920 and DW-0919
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Jun 2012
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult males aged 20 to 55 years at screening.
- No significant congenital/chronic disease.
- No symptoms in physical examination.
- Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
- Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.
Who cannot join
- History of Hyperreactivity with drug ingredients(acetaminophen, tramadol) or opioids.
- History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
- History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, 2-treatment, 2-sequence, Cross-over Study to Compare the Safety and Pharmacokinetics of DW-0919 and DW-0920 After Single Oral Administration in Healthy Male Volunteers
The purpose of this study is to evaluate safety and pharmacokinetics of DW-0919 and DW-0920 in healthy male volunteers under fasting condition.
- Conditions
- Healthy
- Being tested
- DW-0920, DW-0919
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW-0920Drug
Also called Acetaminophen: 325mg, Tramadol: 37.5mg, Wontran ER tab.
Dosage form: Extended release tablet Dosage: 2 tablets
DW-0919Drug
Also called Acetaminophen: 650mg, Tramadol: 75mg
Dosage form: Extended release tablet Dosage: 1 tablet
| Study group | Role | What they receive |
|---|---|---|
| DW-0919 | Active comparator | Not described Receives: Drug: DW-0919 |
| DW-0920 | Experimental | Not described Receives: Drug: DW-0920 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of DW-0919(Acetaminophen, Tramadol)
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
Cmax of DW-0919(Acetaminophen, Tramadol)
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
AUC of DW-0920(Acetaminophen, Tramadol)
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
Cmax of DW-0920(Acetaminophen, Tramadol)
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chungnam National University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606059
- Sponsor's protocol ID
- DW0919-1003
- Acronym
- DW0919-1003
- Status last verified
- Oct 2016
- First submitted
- 23 May 2012
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim HC, Yoon DY, Lee S, Jang IJ, Hong JH, Kim J. Comparative pharmacokinetics between two tablets of tramadol 37.5 mg/acetaminophen 325 mg and one tablet of tramadol 75 mg/acetaminophen 650 mg for extended-release fixed-dose combination. Transl Clin Pharmacol. 2022 Jun;30(2):112-119. doi: 10.12793/tcp.2022.30.e12. Epub 2022 Jun 27.
PubMed 35800670
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
- A Randomized, Open Label, 2-treatment, 2-sequence, Cross-over Study to Compare the Safety and Pharmacokinetics of DW-0919 and DW-0920 After Single Oral Administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01606059
- Acronym / sponsor ID
- DW0919-1003 / DW0919-1003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chungnam National University Hospital
- Study start
- May 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 May 2012 (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 evaluate safety and pharmacokinetics of DW-0919 and DW-0920 in healthy male volunteers under fasting condition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DW-0919 | Active comparator | Drug: DW-0919 |
| DW-0920 | Experimental | Drug: DW-0920 |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult males aged 20 to 55 years at screening.
- No significant congenital/chronic disease.
- No symptoms in physical examination.
- Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
- Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.
Key exclusion criteria (3 listed)
- History of Hyperreactivity with drug ingredients(acetaminophen, tramadol) or opioids.
- History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
- History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
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 |
|---|---|---|
| DW-0920Also: Acetaminophen: 325mg, Tramadol: 37.5mg, Wontran ER tab.Dosage form: Extended release tablet Dosage: 2 tablets | Drug | DW-0920 |
| DW-0919Also: Acetaminophen: 650mg, Tramadol: 75mgDosage form: Extended release tablet Dosage: 1 tablet | Drug | DW-0919 |
Primary outcome
AUC of DW-0919(Acetaminophen, Tramadol)
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
Cmax of DW-0919(Acetaminophen, Tramadol)
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
AUC of DW-0920(Acetaminophen, Tramadol)
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
Cmax of DW-0920(Acetaminophen, Tramadol)
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
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.
- Derived from this study: PubMed 35800670Kim HC, Yoon DY, Lee S, Jang IJ, Hong JH, Kim J. Comparative pharmacokinetics between two tablets of tramadol 37.5 mg/acetaminophen 325 mg and one tablet of tramadol 75 mg/acetaminophen 650 mg for extended-release fixed-dose combination. Transl Clin Pharmacol. 2022 Jun;30(2):112-119. doi: 10.12793/tcp.2022.30.e12. Epub 2022 Jun 27.
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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.
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 DW-0920 and DW-0919 in people with Healthy, run by Daewon 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 5 inclusion and 3 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.
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 of DW-0919(Acetaminophen, Tramadol) (time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01606059, which also lists 1 linked publication.
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.