Food Effect on PK of DW-1021 (Pelubiprofen 45 mg / Tramadol 45.9 mg) in Healthy Adults

Launched by HAIPHONG UNIVERSITY OF MEDICINE AND PHARMACY · Jul 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how food affects the way the body absorbs and processes a new medicine called DW-1021, which combines two drugs, pelubiprofen and tramadol. The study involves healthy adult men who will take a single dose of this medicine twice—once after fasting (without eating) and once after eating a meal. The researchers will take blood samples to see if eating changes how much of the medicine gets into the bloodstream and how long it stays there. They will also carefully watch for any side effects or health changes during the study.

Men between the ages of 20 and 40 who are in good health and meet certain criteria, like having a normal body weight and blood pressure, may be eligible to join. Participants should not have any significant medical problems, recent use of certain medications, or allergies to the study drugs. Throughout the study, volunteers will be closely monitored with tests and heart checks to ensure their safety. If you’re interested, you should be ready to give informed consent and agree to use contraception during the study period. This trial helps researchers understand if food influences how this medicine works, which is important for giving the best advice on how to take it safely and effectively.

Gender

MALE

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