Healthy VolunteersPhase 1DW-1021FNCT07060209
Food Effect on PK of DW-1021 (Pelubiprofen 45 mg / Tramadol 45.9 mg) in Healthy Adults
A Phase 1 study testing DW-1021 in people with Healthy Volunteers and Pharmacokinetics, run by Haiphong University of Medicine and Pharmacy at 2 sites in Vietnam.
Trial summary
This is a Phase 1, open-label, single-dose crossover study designed to evaluate the effect of food on the pharmacokinetics of DW-1021, a fixed-dose combination tablet containing pelubiprofen 45 mg and tramadol 45.9 mg. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Pharmacokinetics, Food Effect in Healthy Volunteers
- What is being tested?
- DW-1021
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesVietnam
- Study dates
- 20 Sep 2025to 25 Nov 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 20 to 40 years at screening visit
- Body Mass Index (BMI) between 18.5 and 24.9 kg/m²
- Body weight greater than 50 kg
- Systolic blood pressure between 100 mmHg and 129 mmHg; diastolic blood pressure less than 84 mmHg
- Regular heart rate ranging from 60 to 90 beats per minute
- No clinically significant medical history or evidence of congenital or chronic diseases, including but not limited to: hypertension, orthostatic hypotension, hypoglycemia when fasting, swallowing difficulties, diabetes, cardiovascular diseases, pulmonary diseases, gastrointestinal diseases, liver insufficiency, renal insufficiency, endocrine disorders, neurological or psychiatric disorders, immunological, hematological, or hereditary diseases, tuberculosis, or infectious diseases
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- Suitable laboratory test results (hematology, urinalysis, blood chemistry, HCV/AIDS, HBsAg, anti-HCV) and electrocardiogram (ECG) at screening: no pathological findings; clinical laboratory parameters within the normal range or, if outside the normal range, not clinically significant as judged by the investigator
- Willing and able to provide written informed consent after being fully informed about the study objectives and possible adverse effects
- Agree to use effective contraception from initial administration until 7 days after the last dose of test or reference drugs
Who cannot join
- Use of drugs that induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 30 days prior to administration, or use of any medication that might affect the study within 10 days prior to administration
- Participation in any other clinical trial within 3 months prior to screening
- Blood donation within 8 weeks prior to drug administration
- History of gastrointestinal surgery that may affect drug absorption
- History of drug abuse, or use of alcohol, drugs, or tobacco products within 1 year before participation
- Known hypersensitivity or allergy to the test or reference drug or their components
- Known genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, which are characterized by symptoms like diarrhea and bloating after consuming dairy products
- Suffering from dysphagia
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam2 sites, 2 recruiting
- Recruiting
Clinical Trial and Bioequivalence Center
Haiphong, Hai Phong, 180000
Phuong Nguyen Thi Thu Phuong, MD, PhD, 0936685007, tvanh@hpmu.edu.vn
Van Anh Tran, Ms, 0343035492, tvanh@hpmu.edu.vn
- Recruiting
Clinical Trial and Bioequivalence Center
Haiphong, Hai Phong, 180000
Van Anh Tran, MSc.Pharm, 0343035492, tvanh@hpmu.edu.vn
Phuong Thi Thu Nguyen, MD, PhD, nttphuong@hpmu.edu.vn
About this study
Official title: A Randomized, Open-label, Single Oral Dose Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Pelubiprofen-Tramadol (DW-1021) Controlled Release Film Coated Tablet (Pelubiprofen 45mg / Tramadol 45.9mg) After Oral Administration in 14 Healthy Adult Vietnamese Male Subjects Under Fed and Fasting Conditions
This is a Phase 1, open-label, single-dose crossover study designed to evaluate the effect of food on the pharmacokinetics of DW-1021, a fixed-dose combination tablet containing pelubiprofen 45 mg and tramadol 45.9 mg. Fourteen healthy adult Vietnamese males will each receive DW-1021 once under fasting conditions and once under fed conditions, with a 14-day washout period in between. Blood samples will be collected to assess how food intake affects the absorption and exposure levels of both active ingredients. Safety, including adverse events, laboratory results, vital signs, and ECGs, will be closely monitored throughout the study.
Read the detailed description
DW-1021 is a fixed-dose combination tablet containing pelubiprofen, a nonsteroidal anti-inflammatory drug (NSAID), and tramadol, a centrally acting analgesic. Combining these two agents is expected to provide multimodal pain relief by targeting both peripheral and central pain pathways while potentially reducing opioid-related side effects.
This Phase 1 study is being conducted to evaluate how a standard high-fat meal affects the rate and extent of absorption of pelubiprofen and tramadol when administered together in DW-1021. A randomized, open-label, two-period, two-sequence crossover design is used to allow each subject to serve as his own control, improving the reliability of the pharmacokinetic comparison between fasting and fed states.
Each of the 14 healthy adult male volunteers will receive a single dose of DW-1021 under fasting conditions in one period and under fed conditions in the other, with a sufficient washout period to prevent carryover effects. Intensive blood sampling will be performed after each dose to measure plasma concentrations of pelubiprofen, its active metabolite (trans-OH-pelubiprofen), tramadol, and O-desmethyl-tramadol. Safety will be monitored throughout, including recording of adverse events, laboratory tests, vital signs, and ECGs.
The data generated will help determine whether food intake has a clinically significant impact on the pharmacokinetic profile of DW-1021 and will support future dosing recommendations and product labeling.
- Being tested
- DW-1021
- Keywords
- Pelubiprofen, DW-1021, Tramadol, Food effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW-1021Drug
A fixed-dose combination controlled release film-coated tablet containing pelubiprofen 45 mg and tramadol 45.9 mg (salt form), administered as a single oral dose under fasting and fed conditions in a two-period, two-sequence crossover design. Each subject receives the intervention once under each condition with a 14-day washout period.
| Study group | Role | What they receive |
|---|---|---|
| DW-1021 Fasting Arm | Experimental | Subjects receive a single oral dose of DW-1021 under fasting conditions in Period 1 or Period 2 of the randomized two-period, two-sequence crossover design. Receives: Drug: DW-1021 |
| DW-1021 Fed Arm | Experimental | Subjects receive a single oral dose of DW-1021 under fed conditions in Period 1 or Period 2 of the randomized two-period, two-sequence crossover design. Receives: Drug: DW-1021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
Cmax of pelubiprofen, tramadol will be assessed following a single oral administration of DW-1021 under fasting and fed conditions to evaluate the effect of food on systemic exposure.
Measured: Up to 48 hours post-dose in each period
Area Under the Concentration-Time Curve (AUC₀-t)
AUC₀-t of pelubiprofen,tramadol will be assessed following a single oral administration of DW-1021 under fasting and fed conditions to evaluate the effect of food on systemic exposure.
Measured: Up to 48 hours post-dose in each period
Secondary outcomes (5)
Cmax of trans-OH-pelubiprofen and O-desmethyl-tramadol
Maximum observed plasma concentration (Cmax) of trans-OH-pelubiprofen and O-desmethyl-tramadol following single oral administration of DW-1021 under fasting or fed condition
Measured: Up to 48 hours post-dose in each period
AUC₀-t of trans-OH-pelubiprofen and O-desmethyl-tramadol
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC₀-t) for trans-OH-pelubiprofen and O-desmethyl-tramadol following single oral administration of DW-1021 under fasting or fed condition
Measured: Up to 48 hours post-dose in each period
Tmax of trans-OH-pelubiprofen and O-desmethyl-tramadol
Time to reach maximum plasma concentration (Tmax) of trans-OH-pelubiprofen and O-desmethyl-tramadol following single oral administration of DW-1021 under fasting or fed condition.
Measured: Up to 48 hours post-dose in each period
t½ of trans-OH-pelubiprofen and O-desmethyl-tramadol
Terminal elimination half-life (t½) of trans-OH-pelubiprofen and O-desmethyl-tramadol following single oral administration of DW-1021 under fasting or fed condition.
Measured: Up to 48 hours post-dose in each period
CL/F of trans-OH-pelubiprofen and O-desmethyl-tramadol
Apparent oral clearance (CL/F) of trans-OH-pelubiprofen and O-desmethyl-tramadol following single oral administration of DW-1021 under fasting or fed condition
Measured: Up to 48 hours post-dose in each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start20 Sep 2025 (estimated)
- Primary completion25 Oct 2025 (estimated)
- Study completion25 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Model description
- A randomized, open-label, two-period, two-sequence crossover design. Each subject will receive DW-1021 once under fasting conditions and once under fed conditions, with a 14-day washout period between periods.
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haiphong University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Daewon Pharmaceutical Co., Ltd., Big Leap Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060209
- Sponsor's protocol ID
- DW-1021F
- Other IDs
- Protocol No. DW-1021F
- Acronym
- DW-1021F
- Status last verified
- Aug 2025
- First submitted
- 28 Jun 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and the limited scope of the Phase I pharmacokinetic study in healthy volunteers. The study does not include plans or infrastructure for external data sharing
Publications
Shin JS, Baek SR, Sohn SI, Cho YW, Lee KT. Anti-inflammatory effect of pelubiprofen, 2-[4-(oxocyclohexylidenemethyl)-phenyl]propionic acid, mediated by dual suppression of COX activity and LPS-induced inflammatory gene expression via NF-kappaB inactivation. J Cell Biochem. 2011 Dec;112(12):3594-603. doi: 10.1002/jcb.23290.
PubMed 21809372Choi IA, Baek HJ, Cho CS, Lee YA, Chung WT, Park YE, Lee YJ, Park YB, Lee J, Lee SS, Yoo WH, Song JS, Kang SW, Kim HA, Song YW. Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, double-blind, phase III, non-inferiority clinical trial. BMC Musculoskelet Disord. 2014 Nov 18;15:375. doi: 10.1186/1471-2474-15-375.
PubMed 25403311Tham BT, Ngan TT, Van Anh T, Chool KD, Ram LA, Wook PS, Bok LS, Ho OD, Van Khai N, Phuong NTT. Pharmacokinetic Evaluation of a Fixed-Dose Combination of Pelubiprofen and Tramadol: A Randomized Crossover Relative Bioavailability Trial and a Fixed-Sequence Food-Effect Study in Healthy Volunteers. Clin Pharmacol Drug Dev. 2026 Mar;15(3):e70050. doi: 10.1002/cpdd.70050.
PubMed 41821212
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Oral Dose Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Pelubiprofen-Tramadol (DW-1021) Controlled Release Film Coated Tablet (Pelubiprofen 45mg / Tramadol 45.9mg) After Oral Administration in 14 Healthy Adult Vietnamese Male Subjects Under Fed and Fasting Conditions
- ClinicalTrials.gov ID
- NCT07060209
- Acronym / sponsor ID
- DW-1021F / DW-1021F
- Keywords
- Pelubiprofen, DW-1021, Tramadol, Food effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Haiphong University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- Daewon Pharmaceutical Co., Ltd., Big Leap Research
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 25 Oct 2025 (estimated)
- Study completion
- 25 Nov 2025 (estimated)
- First posted
- 11 Jul 2025 (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.
This is a Phase 1, open-label, single-dose crossover study designed to evaluate the effect of food on the pharmacokinetics of DW-1021, a fixed-dose combination tablet containing pelubiprofen 45 mg and tramadol 45.9 mg. Fourteen healthy adult Vietnamese males will each receive DW-1021 once under fasting conditions and once under fed conditions, with a 14-day washout period in between. Blood samples will be collected to assess how food intake affects the absorption and exposure levels of both active ingredients. Safety, including adverse events, laboratory results, vital signs, and ECGs, will be closely monitored throughout the study.
Detailed description
DW-1021 is a fixed-dose combination tablet containing pelubiprofen, a nonsteroidal anti-inflammatory drug (NSAID), and tramadol, a centrally acting analgesic. Combining these two agents is expected to provide multimodal pain relief by targeting both peripheral and central pain pathways while potentially reducing opioid-related side effects.
This Phase 1 study is being conducted to evaluate how a standard high-fat meal affects the rate and extent of absorption of pelubiprofen and tramadol when administered together in DW-1021. A randomized, open-label, two-period, two-sequence crossover design is used to allow each subject to serve as his own control, improving the reliability of the pharmacokinetic comparison between fasting and fed states.
Each of the 14 healthy adult male volunteers will receive a single dose of DW-1021 under fasting conditions in one period and under fed conditions in the other, with a sufficient washout period to prevent carryover effects. Intensive blood sampling will be performed after each dose to measure plasma concentrations of pelubiprofen, its active metabolite (trans-OH-pelubiprofen), tramadol, and O-desmethyl-tramadol. Safety will be monitored throughout, including recording of adverse events, laboratory tests, vital signs, and ECGs.
The data generated will help determine whether food intake has a clinically significant impact on the pharmacokinetic profile of DW-1021 and will support future dosing recommendations and product labeling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, open-label, two-period, two-sequence crossover design. Each subject will receive DW-1021 once under fasting conditions and once under fed conditions, with a 14-day washout period between periods.
| Arm | Type | Receives |
|---|---|---|
| DW-1021 Fasting Arm | Experimental | Drug: DW-1021Subjects receive a single oral dose of DW-1021 under fasting conditions in Period 1 or Period 2 of the randomized two-period, two-sequence crossover design. |
| DW-1021 Fed Arm | Experimental | Drug: DW-1021Subjects receive a single oral dose of DW-1021 under fed conditions in Period 1 or Period 2 of the randomized two-period, two-sequence crossover design. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male subjects aged 20 to 40 years at screening visit
- Body Mass Index (BMI) between 18.5 and 24.9 kg/m²
- Body weight greater than 50 kg
- Systolic blood pressure between 100 mmHg and 129 mmHg; diastolic blood pressure less than 84 mmHg
- Regular heart rate ranging from 60 to 90 beats per minute
Key exclusion criteria (8 listed)
- Use of drugs that induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 30 days prior to administration, or use of any medication that might affect the study within 10 days prior to administration
- Participation in any other clinical trial within 3 months prior to screening
- Blood donation within 8 weeks prior to drug administration
- History of gastrointestinal surgery that may affect drug absorption
- History of drug abuse, or use of alcohol, drugs, or tobacco products within 1 year before participation
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-1021A fixed-dose combination controlled release film-coated tablet containing pelubiprofen 45 mg and tramadol 45.9 mg (salt form), administered as a single oral dose under fasting and fed conditions in a two-period, two-sequence crossover design. Each subject receives the intervention once under each condition with a 14-day washout period. | Drug | DW-1021 Fasting Arm, DW-1021 Fed Arm |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: Up to 48 hours post-dose in each period
Cmax of pelubiprofen, tramadol will be assessed following a single oral administration of DW-1021 under fasting and fed conditions to evaluate the effect of food on systemic exposure.
Area Under the Concentration-Time Curve (AUC₀-t)
Time frame: Up to 48 hours post-dose in each period
AUC₀-t of pelubiprofen,tramadol will be assessed following a single oral administration of DW-1021 under fasting and fed conditions to evaluate the effect of food on systemic exposure.
5 secondary outcomes
Cmax of trans-OH-pelubiprofen and O-desmethyl-tramadol
Time frame: Up to 48 hours post-dose in each period
AUC₀-t of trans-OH-pelubiprofen and O-desmethyl-tramadol
Time frame: Up to 48 hours post-dose in each period
Tmax of trans-OH-pelubiprofen and O-desmethyl-tramadol
Time frame: Up to 48 hours post-dose in each period
t½ of trans-OH-pelubiprofen and O-desmethyl-tramadol
Time frame: Up to 48 hours post-dose in each period
CL/F of trans-OH-pelubiprofen and O-desmethyl-tramadol
Time frame: Up to 48 hours post-dose in each period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Results publication: PubMed 21809372Shin JS, Baek SR, Sohn SI, Cho YW, Lee KT. Anti-inflammatory effect of pelubiprofen, 2-[4-(oxocyclohexylidenemethyl)-phenyl]propionic acid, mediated by dual suppression of COX activity and LPS-induced inflammatory gene expression via NF-kappaB inactivation. J Cell Biochem. 2011 Dec;112(12):3594-603. doi: 10.1002/jcb.23290.
- Results publication: PubMed 25403311Choi IA, Baek HJ, Cho CS, Lee YA, Chung WT, Park YE, Lee YJ, Park YB, Lee J, Lee SS, Yoo WH, Song JS, Kang SW, Kim HA, Song YW. Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, double-blind, phase III, non-inferiority clinical trial. BMC Musculoskelet Disord. 2014 Nov 18;15:375. doi: 10.1186/1471-2474-15-375.
- Derived from this study: PubMed 41821212Tham BT, Ngan TT, Van Anh T, Chool KD, Ram LA, Wook PS, Bok LS, Ho OD, Van Khai N, Phuong NTT. Pharmacokinetic Evaluation of a Fixed-Dose Combination of Pelubiprofen and Tramadol: A Randomized Crossover Relative Bioavailability Trial and a Fixed-Sequence Food-Effect Study in Healthy Volunteers. Clin Pharmacol Drug Dev. 2026 Mar;15(3):e70050. doi: 10.1002/cpdd.70050.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and the limited scope of the Phase I pharmacokinetic study in healthy volunteers. The study does not include plans or infrastructure for external data sharing
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Screening Protocol
Pain
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.
2 sites 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-1021 in people with Healthy Volunteers and Pharmacokinetics, run by Haiphong University of Medicine and Pharmacy at 2 sites in Vietnam.
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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phuong Nguyen Thi Thu Phuong, MD, PhD (+84936685007, nttphuong@hpmu.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) (time frame: Up to 48 hours post-dose in each period). 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?
On the ClinicalTrials.gov record for NCT07060209, which also lists 3 linked publications.
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 Aug 2025.