Food Effect on PK of DW-1021 (Pelubiprofen 45 mg / Tramadol 45.9 mg) in Healthy Adults
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorHaiphong University of Medicine and Pharmacy
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 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.
Eligibility criteria
Qualifiers
Healthy male subjects aged 20 to 40 years at screening visit
Body Mass Index (BMI) between 18.5 and 24.9 kg/m²
Body weight greater than 50 kg
Systolic blood pressure between 100 mmHg and 129 mmHg; diastolic blood pressure less than 84 mmHg
Disqualifiers
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
Participation in any other clinical trial within 3 months prior to screening
Blood donation within 8 weeks prior to drug administration
History of gastrointestinal surgery that may affect drug absorption
Trial design
Treatments tested in this trial
- DW-1021
Treatment groups
14 Participants
are divided into 2 treatment groupsSponsors and collaborators
Haiphong University of Medicine and Pharmacy
Lead sponsor
Daewon Pharmaceutical Co., Ltd.
Collaborator
Big Leap Research
Collaborator
Source ClinicalTrials.gov