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

ConditionsHealthy Volunteers Pharmacokinetics Food Effect in Healthy Volunteers

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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

DW-1021
Drug
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.

Treatment groups

14 Participants

are divided into 2 treatment groups

Group A: DW-1021 Fasting ArmExperimental treatment 1 intervention

Group B: DW-1021 Fed ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Maximum Plasma Concentration (Cmax)

Cmax of pelubiprofen, tramadol will be assessed following a single oral administration of DW-1021 under fasting and fed conditions to evaluate the effect of food on systemic exposure.

Time frame