Comparison of DW-1021 and Separate Doses of Pelubi CR and Zytram CR Under Fasting Conditions (DW-1021)

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: DW-1021; Drug: Pelubi CR + Zytram CR

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Phase 1

Contacts and Locations

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

Study Locations

• Vietnam
  • Hai Phong
    • Haiphong, Hai Phong, Vietnam, 180000
      • Recruiting
      • Clinical Trial and Bioequivalence Center
      • Contact: Van Anh Tran, MSc.Pharm; Phone Number: 0343035492; Email: tvanh@hpmu.edu.vn
      • Contact: Phuong Thi Thu Nguyen, MD, PhD; Email: nttphuong@hpmu.edu.vn
    • Haiphong, Hai Phong, Vietnam, 180000
      • Not yet recruiting
      • Clinical Trial and Bioequivalence Center
      • Contact: Van Anh Tran, MSc.Pharm; Phone Number: 0343035492; Email: tvanh@hpmu.edu.vn
      • Contact: Phuong Thi Thu Nguyen, MD, PhD; Phone Number: +84-0936685007; Email: nttphuong@hpmu.edu.vn
      • Principal Investigator: Phuong Thi Thu Nguyen, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A: Test → Reference; Participants in this arm will receive the test drug DW-1021 (Pelubiprofen 45 mg - Tramadol 45.9 mg salt) in Period I, followed by the reference drugs-Pelubi CR 45 mg and Zytram CR 75 mg-in Period II. A 14-day washout period separates the two dosing periods.	Drug: DW-1021; 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.; Other Names: Pelubiprofen 45 mg - Tramadol 45.9 mg salt combination; Pelubiprofen-Tramadol fixed-dose combination; Drug: Pelubi CR + Zytram CR; 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.; Other Names: Pelubiprofen 45 mg controlled-release tablet; Tramadol HCl 75 mg controlled-release tablet
Active Comparator: Sequence B: Reference → Test; Participants in this arm will receive the reference drugs-Pelubi CR 45 mg and Zytram CR 75 mg-in Period I, followed by the test drug DW-1021 (Pelubiprofen 45 mg - Tramadol 45.9 mg salt) in Period II. A 14-day washout period separates the two dosing periods.	Drug: DW-1021; 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.; Other Names: Pelubiprofen 45 mg - Tramadol 45.9 mg salt combination; Pelubiprofen-Tramadol fixed-dose combination; Drug: Pelubi CR + Zytram CR; 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.; Other Names: Pelubiprofen 45 mg controlled-release tablet; Tramadol HCl 75 mg controlled-release tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0 to 48 hours post-dose in each period
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.	0 to 48 hours post-dose in each period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0 to 48 hours post-dose in each period
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.	0 to 48 hours post-dose in each period
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.	0 to 48 hours post-dose in each period

Collaborators and Investigators

• Sponsor: Haiphong University of Medicine and Pharmacy
• Collaborators: Daewon Pharmaceutical Co., Ltd.; Big Leap Research

Publications and helpful links

General Publications

• Choi IA, Baek HJ, Cho CS, Lee YA, Chung WT, Park YE, Lee YJ, Park YB, Lee J, Lee SS, Yoo WH, Song JS, Kang SW, Kim HA, Song YW. Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, double-blind, phase III, non-inferiority clinical trial. BMC Musculoskelet Disord. 2014 Nov 18;15:375. doi: 10.1186/1471-2474-15-375.
• Shin JS, Baek SR, Sohn SI, Cho YW, Lee KT. Anti-inflammatory effect of pelubiprofen, 2-[4-(oxocyclohexylidenemethyl)-phenyl]propionic acid, mediated by dual suppression of COX activity and LPS-induced inflammatory gene expression via NF-kappaB inactivation. J Cell Biochem. 2011 Dec;112(12):3594-603. doi: 10.1002/jcb.23290.

Study record dates

Study Major Dates

• Study Start (Estimated): September 20, 2025
• Primary Completion (Estimated): September 25, 2025
• Study Completion (Estimated): October 25, 2025

Study Registration Dates

• First Submitted: June 15, 2025
• First Submitted That Met QC Criteria: June 15, 2025
• First Posted (Actual): June 24, 2025

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Pelubiprofen; Bioavailability; Tramadol; Fixed-Dose Combination; DW-1021
• Additional Relevant MeSH Terms: Organic Chemicals; Lipids; Amines; Alcohols; Cyclohexanols; Hexanols; Fatty Alcohols; Dimethylamines; Methylamines; Tramadol; pelubiprofen
• Other Study ID Numbers: DW-1021; Protocol No. DW-1021 (Other Identifier: Daewon Pharmaceutical Co., Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to privacy concerns and the limited scope of the Phase I pharmacokinetic study in healthy volunteers. The study does not include plans or infrastructure for external data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No