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RECRUITING

NCT07060209

PHASE1

Food Effect on PK of DW-1021 (Pelubiprofen 45 mg / Tramadol 45.9 mg) in Healthy Adults

Sponsor: Haiphong University of Medicine and Pharmacy

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Open-label, Single Oral Dose Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Pelubiprofen-Tramadol (DW-1021) Controlled Release Film Coated Tablet (Pelubiprofen 45mg / Tramadol 45.9mg) After Oral Administration in 14 Healthy Adult Vietnamese Male Subjects Under Fed and Fasting Conditions

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09-20

Completion Date

2025-11-25

Last Updated

2025-08-28

Healthy Volunteers

Yes

Conditions

Healthy Volunteers Pharmacokinetics Food Effect in Healthy Volunteers

Interventions

DRUG

DW-1021

A fixed-dose combination controlled release film-coated tablet containing pelubiprofen 45 mg and tramadol 45.9 mg (salt form), administered as a single oral dose under fasting and fed conditions in a two-period, two-sequence crossover design. Each subject receives the intervention once under each condition with a 14-day washout period.

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 ranging from 60 to 90 beats per minute 6. No clinically significant medical history or evidence of congenital or chronic diseases, including but not limited to: hypertension, orthostatic hypotension, hypoglycemia when fasting, swallowing difficulties, diabetes, cardiovascular diseases, pulmonary diseases, gastrointestinal diseases, liver insufficiency, renal insufficiency, endocrine disorders, neurological or psychiatric disorders, immunological, hematological, or hereditary diseases, tuberculosis, or infectious diseases 7. Suitable laboratory test results (hematology, urinalysis, blood chemistry, HCV/AIDS, HBsAg, anti-HCV) and electrocardiogram (ECG) at screening: no pathological findings; clinical laboratory parameters within the normal range or, if outside the normal range, not clinically significant as judged by the investigator 8. Willing and able to provide written informed consent after being fully informed about the study objectives and possible adverse effects 9. Agree to use effective contraception from initial administration until 7 days after the last dose of test or reference drugs Exclusion Criteria: 1. 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 2. Participation in any other clinical trial within 3 months prior to screening 3. Blood donation within 8 weeks prior to drug administration 4. History of gastrointestinal surgery that may affect drug absorption 5. History of drug abuse, or use of alcohol, drugs, or tobacco products within 1 year before participation 6. Known hypersensitivity or allergy to the test or reference drug or their components 7. Known genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, which are characterized by symptoms like diarrhea and bloating after consuming dairy products 8. Suffering from dysphagia

Locations (2)

Clinical Trial and Bioequivalence Center

Haiphong, Hai Phong, Vietnam