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

NCT07032558 | Recruiting Phase 1

• 2 other identifiers: DW-1021Protocol No. DW-1021
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy Volunteer

Keywords

Pelubiprofen; Tramadol; DW-1021; Pharmacokinetics; Fixed-Dose Combination; Bioavailability

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Area under the curve extrapolated to infinity (AUC∞)

  0 to 48 hours post-dose in each period

• Terminal elimination half-life (t1/2)

  0 to 48 hours post-dose in each period

• Time to reach maximum plasma concentration (Tmax)

  0 to 48 hours post-dose in each period

Study Arms (2)

Sequence A: Test → Reference

EXPERIMENTAL

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; Drug: Pelubi CR + Zytram CR

Sequence B: Reference → Test

ACTIVE COMPARATOR

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; Drug: Pelubi CR + Zytram CR

Interventions

DW-1021 DRUG

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.

Also known as: Pelubiprofen 45 mg - Tramadol 45.9 mg salt combination, Pelubiprofen-Tramadol fixed-dose combination

Sequence A: Test → Reference; Sequence B: Reference → Test

Pelubi CR + Zytram CR DRUG

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.

Also known as: Pelubiprofen 45 mg controlled-release tablet, Tramadol HCl 75 mg controlled-release tablet

Sequence A: Test → Reference; Sequence B: Reference → Test

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haiphong University of Medicine and Pharmacy: lead
• Daewon Pharmaceutical Co., Ltd.: collaborator
• Big Leap Research: collaborator

Study Sites (2)

Clinical Trial and Bioequivalence Center

Haiphong, Hai Phong, 180000, Vietnam

NOT YET RECRUITING

Clinical Trial and Bioequivalence Center

Haiphong, Hai Phong, 180000, Vietnam

RECRUITING

Related Publications (2)

• 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.

  PMID: 25403311 BACKGROUND

• 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.

  PMID: 21809372 BACKGROUND

MeSH Terms

Interventions

pelubiprofen; Tramadol

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Central Study Contacts

Nguyen Thi Thu Phuong, MD, PhD

CONTACT

+84936685007; nttphuong@hpmu.edu.vn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. No parties are masked.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, open-label, single-dose, 2-treatment, 2-period, 2-sequence (2x2) crossover study conducted under fasting conditions. Fourteen healthy male volunteers will be randomly assigned to one of two sequences: Test-Reference (Group A) or Reference-Test (Group B), with a 14-day washout period between dosing periods. The test drug (DW-1021, Pelubiprofen 45 mg - Tramadol 45.9 mg salt) or the reference drugs (Pelubi CR 45 mg and Zytram CR 75 mg) will be administered orally with 150 mL of water after at least 10 hours of fasting. Blood samples will be collected up to 48 hours post-dose in each period for pharmacokinetic evaluation.

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: June 24, 2025
• Study Start: September 20, 2025
• Primary Completion: September 25, 2025
• Study Completion: October 25, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)