Food Effect on PK of DW-1021 (Pelubiprofen 45 mg / Tramadol 45.9 mg) in Healthy Adults

NCT07060209 | Recruiting Phase 1

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

Brief Summary

This is a Phase 1, open-label, single-dose crossover study designed to evaluate the effect of food on the pharmacokinetics of DW-1021, a fixed-dose combination tablet containing pelubiprofen 45 mg and tramadol 45.9 mg. Fourteen healthy adult Vietnamese males will each receive DW-1021 once under fasting conditions and once under fed conditions, with a 14-day washout period in between. Blood samples will be collected to assess how food intake affects the absorption and exposure levels of both active ingredients. Safety, including adverse events, laboratory results, vital signs, and ECGs, will be closely monitored throughout the study.

Conditions

Healthy Volunteers; Pharmacokinetics; Food Effect in Healthy Volunteers

Keywords

Pelubiprofen; DW-1021; Tramadol; Food effect

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma Concentration (Cmax)

  Cmax of pelubiprofen, tramadol will be assessed following a single oral administration of DW-1021 under fasting and fed conditions to evaluate the effect of food on systemic exposure.

  Up to 48 hours post-dose in each period

• Area Under the Concentration-Time Curve (AUC₀-t)

  AUC₀-t of pelubiprofen,tramadol will be assessed following a single oral administration of DW-1021 under fasting and fed conditions to evaluate the effect of food on systemic exposure.

  Up to 48 hours post-dose in each period

Secondary Outcomes (5)

• Cmax of trans-OH-pelubiprofen and O-desmethyl-tramadol

  Up to 48 hours post-dose in each period

• AUC₀-t of trans-OH-pelubiprofen and O-desmethyl-tramadol

  Up to 48 hours post-dose in each period

• Tmax of trans-OH-pelubiprofen and O-desmethyl-tramadol

  Up to 48 hours post-dose in each period

• t½ of trans-OH-pelubiprofen and O-desmethyl-tramadol

  Up to 48 hours post-dose in each period

• CL/F of trans-OH-pelubiprofen and O-desmethyl-tramadol

  Up to 48 hours post-dose in each period

Study Arms (2)

DW-1021 Fasting Arm

EXPERIMENTAL

Subjects receive a single oral dose of DW-1021 under fasting conditions in Period 1 or Period 2 of the randomized two-period, two-sequence crossover design.

Drug: DW-1021

DW-1021 Fed Arm

EXPERIMENTAL

Subjects receive a single oral dose of DW-1021 under fed conditions in Period 1 or Period 2 of the randomized two-period, two-sequence crossover design.

Drug: DW-1021

Interventions

DW-1021 DRUG

A fixed-dose combination controlled release film-coated tablet containing pelubiprofen 45 mg and tramadol 45.9 mg (salt form), administered as a single oral dose under fasting and fed conditions in a two-period, two-sequence crossover design. Each subject receives the intervention once under each condition with a 14-day washout period.

DW-1021 Fasting Arm; DW-1021 Fed Arm

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

RECRUITING

Clinical Trial and Bioequivalence Center

Haiphong, Hai Phong, 180000, Vietnam

RECRUITING

Related Publications (2)

• 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

• 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

Central Study Contacts

Phuong Nguyen Thi Thu Phuong, MD, PhD

CONTACT

+84936685007; nttphuong@hpmu.edu.vn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, open-label, two-period, two-sequence crossover design. Each subject will receive DW-1021 once under fasting conditions and once under fed conditions, with a 14-day washout period between periods.

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 11, 2025
• Study Start: September 20, 2025
• Primary Completion: October 25, 2025
• Study Completion: November 25, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)