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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: nttphuong@hpmu.edu.vn
• Phone: +84936685007

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Levetiracetam Dosing in Critically Ill on CRRT

  This study tests how levetiracetam behaves in the bodies of adults on continuous renal replacement therapy to help figure out the best dosing.

  Recruiting Chulalongkorn University · Pathum Wan, Bangkok · NCT07918833

• Trigonelline Monohydrate for NAD+ Metabolism in Healthy Adults

  A small study in healthy adults tests whether taking trigonelline monohydrate by mouth for 4 weeks can change NAD+ levels and how the body handles the supplement, compared with NMN and placebo.

  Recruiting Phase 1 dsm-firmenich Switzerland AG · Guelph, Ontario - on · NCT07880925

• Cetuximab bioequivalence test in healthy men

  This study tests whether a cetuximab injection is bioequivalent to Erbitux in healthy men to see if they behave the same in the body.

  Recruiting Phase 1 HC Biopharma Inc. · Haikou, Hainan · NCT07813468

• GenSci142 as a vaginal treatment for bacterial vaginosis

  This study tests whether GenSci142 given as vaginal doses is safe and may help BV patients aged 18–50 compared with clindamycin cream.

  Recruiting at 9 sites Phase 1 Changchun GeneScience Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality and 8 other locations · NCT07663838

• Food effects on AJ201 absorption and safety in healthy Japanese and White men.

  This test checks whether taking AJ201 with food changes how the drug is absorbed and whether it is safe in healthy Japanese and White men.

  Recruiting Phase 1 AnnJi Pharmaceutical Co., Ltd. · Los Alamitos, California · NCT07549919

• High-potency cannabis effects immediately and after a short break

  This test will try smoked cannabis at about 50 mg and 100 mg THC versus placebo in adults who smoke cannabis nearly every day to see how it affects them right away and after a short period without use.

  Recruiting Phase 1 University of California, Los Angeles · Los Angeles, California · NCT06859723

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.