DW-1021 combination pill versus taking Pelubi CR plus Zytram CR while fasting

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 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.

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 Not yet recruiting

Study contacts

• Study coordinator: Nguyen Thi Thu Phuong, MD, PhD
• Email: nttphuong@hpmu.edu.vn
• Phone: +84936685007

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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.