Comparison of DW-1021 and Separate Doses of Pelubi CR and Zytram CR Under Fasting Conditions
A Randomized, Open-label, Single Oral Dose, Two-period, Cross-over Trial to Evaluate the Pharmacokinetics of Pelubiprofen-Tramadol (DW-1021) Controlled Release Film Coated Tablets (Pelubiprofen 45mg-Tramadol 45.9mg Salt) (Test Drug) in Comparison With the Co-administration of Each of Pelubi CR 45mg Controlled Release Film Coated Tablets (Pelubiprofen 45mg) and Zytram CR 75mg Controlled Release Film Coated Tablets (Tramadol HCl 75mg) in Healthy Adult Vietnamese Male Subjects Under Fasting Condition
Haiphong University of Medicine and Pharmacy
14 participants
Sep 20, 2025
INTERVENTIONAL
Conditions
Summary
This is a Phase 1, randomized, open-label, single-dose, two-period, cross-over study to evaluate the pharmacokinetics (PK) of DW-1021, a fixed-dose combination tablet containing Pelubiprofen 45 mg and Tramadol 45.9 mg (as a salt), in healthy adult Vietnamese male volunteers. The study compares DW-1021 with the co-administration of two reference drugs: Pelubi CR 45 mg (Pelubiprofen) and Zytram CR 75 mg (Tramadol HCl), under fasting conditions. A total of 14 eligible participants will be randomly assigned to receive either the test drug followed by the reference drugs, or vice versa, with a 14-day washout period between the two dosing periods. Blood samples will be collected over a 48-hour period after each administration to evaluate drug concentrations. The main purpose is to assess and compare the rate and extent of absorption (Cmax, AUC) of the test and reference products. The study is sponsored by Haiphong University of Medicine and Pharmacy in collaboration with Daewon Pharmaceutical Co., Ltd. It is conducted under ethical approval by the National Ethics Committee in Biomedical Research of Vietnam.
Eligibility
Inclusion Criteria9
- Healthy male subjects aged 20 to 40 years at screening visit
- Body Mass Index (BMI) between 18.5 and 24.9 kg/m²
- Body weight greater than 50 kg
- Systolic blood pressure between 100 mmHg and 129 mmHg; diastolic blood pressure less than 84 mmHg
- Regular heart rate ranging from 60 to 90 beats per minute
- 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
- 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
- Willing and able to provide written informed consent after being fully informed about the study objectives and possible adverse effects
- Agree to use effective contraception from initial administration until 7 days after the last dose of test or reference drugs
Exclusion Criteria8
- 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
- Participation in any other clinical trial within 3 months prior to screening
- Blood donation within 8 weeks prior to drug administration
- History of gastrointestinal surgery that may affect drug absorption
- History of drug abuse, or use of alcohol, drugs, or tobacco products within 1 year before participation
- Known hypersensitivity or allergy to the test or reference drug or their components
- 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
- Suffering from dysphagia
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Interventions
DW-1021 is a fixed-dose combination tablet containing Pelubiprofen 45 mg and Tramadol 45.9 mg (as a salt), formulated as a controlled-release film-coated tablet. It is administered as a single oral dose with 150 mL of water under fasting conditions for the evaluation of pharmacokinetics in healthy adult male volunteers.
The reference treatment consists of two separate controlled-release film-coated tablets: Pelubi CR (Pelubiprofen 45 mg) and Zytram CR (Tramadol HCl 75 mg). These are co-administered as a single oral dose with 150 mL of water under fasting conditions to compare the pharmacokinetic profile against the fixed-dose combination DW-1021.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07032558