Food Effect on PK of DW-1021 (Pelubiprofen 45 mg / Tramadol 45.9 mg) in Healthy Adults
Recruiting
Phase 1
Interventional Study
Healthy Volunteers
Pharmacokinetics
Food Effect in Healthy Volunteers
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.
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, 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…
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…
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