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

Not Applicable

Recruiting

• Conditions: Healthy Volunteers; Food Effect in Healthy Volunteers; Pharmacokinetics
• Interventions: Drug: DW-1021

• Registration Number: NCT07060209
• Lead Sponsor: Haiphong University of Medicine and Pharmacy

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.

Detailed Description

DW-1021 is a fixed-dose combination tablet containing pelubiprofen, a nonsteroidal anti-inflammatory drug (NSAID), and tramadol, a centrally acting analgesic. Combining these two agents is expected to provide multimodal pain relief by targeting both peripheral and central pain pathways while potentially reducing opioid-related side effects.

This Phase 1 study is being conducted to evaluate how a standard high-fat meal affects the rate and extent of absorption of pelubiprofen and tramadol when administered together in DW-1021. A randomized, open-label, two-period, two-sequence crossover design is used to allow each subject to serve as his own control, improving the reliability of the pharmacokinetic comparison between fasting and fed states.

Each of the 14 healthy adult male volunteers will receive a single dose of DW-1021 under fasting conditions in one period and under fed conditions in the other, with a sufficient washout period to prevent carryover effects. Intensive blood sampling will be performed after each dose to measure plasma concentrations of pelubiprofen, its active metabolite (trans-OH-pelubiprofen), tramadol, and O-desmethyl-tramadol. Safety will be monitored throughout, including recording of adverse events, laboratory tests, vital signs, and ECGs.

The data generated will help determine whether food intake has a clinically significant impact on the pharmacokinetic profile of DW-1021 and will support future dosing recommendations and product labeling.

Study Timeline

• Study First Submitted: 2025-06-28
• Study First Submitted QC: 2025-07-08
• Study First Posted: 2025-07-11
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-22
• Last Update Posted: 2025-08-28
• Study Start: 2025-09-20
• Primary Completion: 2025-10-25
• Study Completion: 2025-11-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DW-1021 Fasting Arm	DW-1021	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.
DW-1021 Fed Arm	DW-1021	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.

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax)	Up to 48 hours post-dose in each period	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.
Area Under the Concentration-Time Curve (AUC₀-t)	Up to 48 hours post-dose in each period	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.

Secondary Outcome Measures

Name	Time	Method
Cmax of trans-OH-pelubiprofen and O-desmethyl-tramadol	Up to 48 hours post-dose in each period	Maximum observed plasma concentration (Cmax) of trans-OH-pelubiprofen and O-desmethyl-tramadol following single oral administration of DW-1021 under fasting or fed condition
AUC₀-t of trans-OH-pelubiprofen and O-desmethyl-tramadol	Up to 48 hours post-dose in each period	Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC₀-t) for trans-OH-pelubiprofen and O-desmethyl-tramadol following single oral administration of DW-1021 under fasting or fed condition
Tmax of trans-OH-pelubiprofen and O-desmethyl-tramadol	Up to 48 hours post-dose in each period	Time to reach maximum plasma concentration (Tmax) of trans-OH-pelubiprofen and O-desmethyl-tramadol following single oral administration of DW-1021 under fasting or fed condition.
t½ of trans-OH-pelubiprofen and O-desmethyl-tramadol	Up to 48 hours post-dose in each period	Terminal elimination half-life (t½) of trans-OH-pelubiprofen and O-desmethyl-tramadol following single oral administration of DW-1021 under fasting or fed condition.
CL/F of trans-OH-pelubiprofen and O-desmethyl-tramadol	Up to 48 hours post-dose in each period	Apparent oral clearance (CL/F) of trans-OH-pelubiprofen and O-desmethyl-tramadol following single oral administration of DW-1021 under fasting or fed condition

Trial Locations

Locations (1)

Clinical Trial and Bioequivalence Center; 🇻🇳 Haiphong, Hai Phong, Vietnam