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.
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
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
Crossover
DW-1021
DrugDW-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.
Pelubi CR + Zytram CR
DrugThe 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.
Maximum plasma concentration (Cmax)
Cmax represents the peak plasma concentration of the drug after administration. It is used to compare the rate of absorption between the test and reference products.
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt)
AUCt is a pharmacokinetic parameter representing the total drug exposure from administration to the last quantifiable time point. It is used to compare the extent of absorption between DW-1021 and the reference drugs.
Area under the curve extrapolated to infinity (AUC∞)
AUC∞ represents the total drug exposure over time, extrapolated beyond the last measured concentration. It helps assess complete systemic exposure.
Terminal elimination half-life (t1/2)
The time it takes for the plasma concentration of the drug to decrease by 50%. It is used to understand the drug elimination kinetics.
Time to reach maximum plasma concentration (Tmax)
Tmax is defined as the time point at which the maximum plasma drug concentration is observed following drug administration. It is used to compare the absorption rate between DW-1021 and the reference products.
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Haiphong University of Medicine and Pharmacy
Lead sponsor
Daewon Pharmaceutical Co., Ltd.
Collaborator
Big Leap Research
Collaborator
