DW-1021 combination pill versus taking Pelubi CR plus Zytram CR while fasting
A Randomized, Open-label, Single Oral Dose, Two-period, Cross-over Trial to Evaluate the Pharmacokinetics of Pelubiprofen-Tramadol (DW-1021) Controlled Release Film Coated Tablets (Pelubiprofen 45mg-Tramadol 45.9mg Salt) (Test Drug) in Comparison With the Co-administration of Each of Pelubi CR 45mg Controlled Release Film Coated Tablets (Pelubiprofen 45mg) and Zytram CR 75mg Controlled Release Film Coated Tablets (Tramadol HCl 75mg) in Healthy Adult Vietnamese Male Subjects Under Fasting Condition
This study will test whether a single DW-1021 combination pill produces similar blood levels to taking Pelubi CR and Zytram CR separately in healthy adult Vietnamese men.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Male |
| Sponsor | Haiphong University of Medicine and Pharmacy Academic / other |
| Locations | 2 sites (Haiphong, Hai Phong and 1 other locations) |
| Trial ID | NCT07032558 on ClinicalTrials.gov |
What this trial studies
This Phase 1, randomized, open-label, single-dose, two-period crossover trial enrolls 14 healthy adult male volunteers to compare the pharmacokinetics of DW-1021 (pelubiprofen + tramadol) with co‑administration of Pelubi CR and Zytram CR under fasting conditions. Participants are randomized to one of two dosing sequences with a 14-day washout between periods and blood sampling up to 48 hours after each dose. Primary endpoints are peak concentration (Cmax) and area under the curve (AUC); secondary PK measures include Tmax, AUC∞, and half-life. Safety is monitored with adverse event reporting, vital signs, labs, and physical exams throughout the study.
Who should consider this trial
Good fit: Healthy Vietnamese men aged 20–40 years with BMI 18.5–24.9 kg/m², body weight over 50 kg, normal vital signs, and no clinically significant medical history are the intended participants.
Not a fit: People with pain conditions who need therapeutic treatment, women, those outside the required age/BMI ranges, or anyone with significant medical issues would not gain clinical benefit from participating in this pharmacokinetic study.
Why it matters
Potential benefit: If results show similar absorption, DW-1021 could simplify dosing by combining pelubiprofen and tramadol into a single pill with comparable blood levels to the separate products.
How similar studies have performed: Pharmacokinetic crossover comparisons are a standard and well‑validated method, and similar fixed‑dose combination PK studies have often shown comparable absorption, though DW-1021 itself is a novel formulation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy male subjects aged 20 to 40 years at screening visit 2. Body Mass Index (BMI) between 18.5 and 24.9 kg/m² 3. Body weight greater than 50 kg 4. Systolic blood pressure between 100 mmHg and 129 mmHg; diastolic blood pressure less than 84 mmHg 5. Regular heart rate ranging from 60 to 90 beats per minute 6. 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 7. 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 8. Willing and able to provide written informed consent after being fully informed about the study objectives and possible adverse effects 9. Agree to use effective contraception from initial administration until 7 days after the last dose of test or reference drugs Exclusion Criteria: 1. 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 2. Participation in any other clinical trial within 3 months prior to screening 3. Blood donation within 8 weeks prior to drug administration 4. History of gastrointestinal surgery that may affect drug absorption 5. History of drug abuse, or use of alcohol, drugs, or tobacco products within 1 year before participation 6. Known hypersensitivity or allergy to the test or reference drug or their components 7. 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 8. Suffering from dysphagia
Where this trial is running
Haiphong, Hai Phong and 1 other locations
- Clinical Trial and Bioequivalence Center — Haiphong, Hai Phong, Vietnam (Not_yet_recruiting)
- Clinical Trial and Bioequivalence Center — Haiphong, Hai Phong, Vietnam (Recruiting)
Study contacts
- Study coordinator: Nguyen Thi Thu Phuong, MD, PhD
- Email: nttphuong@hpmu.edu.vn
- Phone: +84936685007
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.