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

Recruiting Phase 1 Interventional Study
Healthy Volunteer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 45
Sex
Male
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
14 (estimated)
Sponsor
Haiphong University of Medicine and Pharmacy · Other
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About This Trial
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 7…
Trial Locations
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Eligibility Criteria
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 rangi…
Contacts

Nguyen Thi Thu Phuong, MD, PhD

+84936685007

nttphuong@hpmu.edu.vn

CONTACT