Actively Recruiting
Food Effect on PK of DW-1021 (Pelubiprofen 45 mg / Tramadol 45.9 mg) in Healthy Adults
Led by Haiphong University of Medicine and Pharmacy · Updated on 2025-08-28
14
Participants Needed
2
Research Sites
9 weeks
Total Duration
On this page
Sponsors
H
Haiphong University of Medicine and Pharmacy
Lead Sponsor
D
Daewon Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Food Effect on PK of DW-1021 (Pelubiprofen 45 mg / Tramadol 45.9 mg) in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male subjects aged 20 to 40 years at screening
- Body Mass Index (BMI) between 18.5 and 24.9 kg/m²
- Body weight greater than 50 kg
- Systolic blood pressure between 100 and 129 mmHg; diastolic blood pressure less than 84 mmHg
- Regular heart rate between 60 and 90 beats per minute
- No clinically significant medical history or chronic diseases including hypertension, diabetes, cardiovascular, pulmonary, gastrointestinal, liver, renal, endocrine, neurological, psychiatric, immunological, hematological, hereditary, tuberculosis, or infectious diseases
- Normal or non-clinically significant laboratory test results and ECG at screening
- Willing and able to provide written informed consent
- Agree to use effective contraception from initial administration until 7 days after last dose
You will not qualify if you...
- Use of enzyme-inducing or inhibiting drugs within 30 days or any medication affecting the study within 10 days prior to administration
- Participation in another clinical trial within 3 months prior to screening
- Blood donation within 8 weeks prior to drug administration
- History of gastrointestinal surgery affecting drug absorption
- History of drug abuse or use of alcohol, drugs, or tobacco within 1 year before participation
- Known hypersensitivity or allergy to the study drug or components
- Known genetic disorders causing intolerance to dairy products
- Suffering from swallowing difficulties (dysphagia)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Clinical Trial and Bioequivalence Center
Haiphong, Hai Phong, Vietnam, 180000
Actively Recruiting
2
Clinical Trial and Bioequivalence Center
Haiphong, Hai Phong, Vietnam, 180000
Actively Recruiting
Research Team
P
Phuong Nguyen Thi Thu Phuong, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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