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

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.

This clinical trial is designed to evaluate and compare the pharmacokinetic characteristics of DW-1021, a fixed-dose combination of Pelubiprofen and Tramadol in salt form (Pelubiprofen 45 mg - Tramadol 45.9 mg), with the co-administration of the individual components-Pelubi CR 45 mg (controlled release Pelubiprofen) and Zytram CR 75 mg (controlled release Tramadol hydrochloride)-in healthy adult male Vietnamese volunteers under fasting conditions.

This is an open-label, randomized, single-dose, two-treatment, two-period, two-sequence crossover study. Fourteen eligible participants will be randomized into two sequences: Test-Reference (TR) and Reference-Test (RT), with each dosing period separated by a 14-day washout. Study drugs will be administered in a fasted state, and blood samples will be collected at multiple time points up to 48 hours post-dose for pharmacokinetic analysis.

The primary PK parameters include Cmax and AUCt. Secondary PK parameters include Tmax, AUC∞, and t1/2. Safety will be monitored through assessment of adverse events, vital signs, clinical laboratory tests, and physical examinations throughout the study.

The trial is sponsored by Haiphong University of Medicine and Pharmacy. Analytical testing of plasma concentrations will be performed by Invites Bio-Core, and CRO support is provided by Big Leap Clinical Research Support JSC. The study is approved by the National Ethics Committee in Biomedical Research of Vietnam (Approval No. 277/CN-HĐĐĐ, dated 12/12/2024). This study was additionally approved for protocol amendments by the Vietnamese Ministry of Health under Decision No. 3840/QĐ-BYT, dated December 19, 2024.

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