Actively Recruiting
Comparison of DW-1021 and Separate Doses of Pelubi CR and Zytram CR Under Fasting Conditions
Led by Haiphong University of Medicine and Pharmacy · Updated on 2025-08-28
14
Participants Needed
2
Research Sites
5 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, 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
Official Title
Comparison of DW-1021 and Separate Doses of Pelubi CR and Zytram CR Under Fasting Conditions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects aged 20 to 40 years at screening
- Body mass index between 18.5 and 24.9 kg/m²
- Body weight over 50 kg
- Systolic blood pressure between 100 and 129 mmHg, diastolic blood pressure below 84 mmHg
- Regular heart rate between 60 and 90 beats per minute
- No significant medical history or chronic diseases such as hypertension, diabetes, cardiovascular, pulmonary, gastrointestinal, liver, renal, endocrine, neurological, psychiatric, immunological, hematological, hereditary, tuberculosis, or infectious diseases
- Normal or clinically acceptable laboratory and ECG results at screening
- Willing and able to provide written informed consent
- Agree to use effective contraception from drug administration until 7 days after last dose
You will not qualify if you...
- Use of enzyme-inducing or inhibiting drugs within 30 days before dosing, or any medication affecting the study within 10 days
- Participation in another clinical trial within 3 months prior to screening
- Blood donation within 8 weeks before 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 allergy to study drugs or their components
- Genetic disorders causing intolerance to dairy products (galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption)
- Difficulty swallowing (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
Not Yet Recruiting
2
Clinical Trial and Bioequivalence Center
Haiphong, Hai Phong, Vietnam, 180000
Actively Recruiting
Research Team
N
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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