💬In plain words
What the trial is, and whether it could suit you
This is a Phase 1, open-label, single-dose crossover study designed to evaluate the effect of food on the pharmacokinetics of DW-1021, a fixed-dose combination tablet containing pelubiprofen 45 mg and tramadol 45.9 mg. Fourteen healthy adult Vietnamese males will each receive DW-1021 once under fasting conditions and once under fed conditions, with a 14-day washout period in between. Blood samples will be collected to assess how food intake affects the absorption and exposure levels of both active ingredients. Safety, including adverse events, laboratory results, vital signs, and ECGs, will be closely monitored throughout the study.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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