Food's effect on how DW-1021 (pelubiprofen 45 mg + tramadol 45.9 mg) is absorbed in healthy adults

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 study will test whether eating a high-fat meal changes how DW-1021 (pelubiprofen plus tramadol) is absorbed in healthy adult 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: NCT07060209 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, open-label, randomized two-period crossover in 14 healthy Vietnamese male volunteers who each receive a single dose of DW-1021 once fasting and once after a standard high-fat meal with a 14-day washout. Intensive blood sampling after each dose will measure plasma levels of pelubiprofen, its active metabolite (trans-OH-pelubiprofen), tramadol, and O-desmethyl-tramadol to compare rate and extent of absorption between fed and fasting states. Safety monitoring will include adverse event recording, laboratory tests, vital signs, and ECGs throughout the study. The crossover design lets each participant serve as their own control to improve the precision of the food-effect comparison.

Who should consider this trial

Good fit: Healthy male adults aged 20–40 years with BMI 18.5–24.9 kg/m², body weight >50 kg, and no clinically significant medical conditions are the intended participants.

Not a fit: People with chronic pain conditions, women, older adults, or those with liver, kidney, or other chronic medical conditions are unlikely to benefit directly from this Phase 1 food-effect study.

Why it matters

Potential benefit: If successful, the results could inform dosing and meal recommendations so patients get more consistent pain relief and fewer unexpected side effects.

How similar studies have performed: Food-effect pharmacokinetic studies are routine and many oral analgesics show altered absorption with high-fat meals, though the specific DW-1021 fixed-dose combination is a novel formulation.

Eligibility 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 (Recruiting)
• Clinical Trial and Bioequivalence Center — Haiphong, Hai Phong, Vietnam (Recruiting)

Study contacts

• Study coordinator: Phuong Nguyen Thi Thu Phuong, MD, PhD

Conditions Healthy Volunteers; Pharmacokinetics; Food Effect in Healthy Volunteers; Pelubiprofen; DW-1021; Tramadol; Food effect