Clinical Research Directory

A Phase 1, Open-Label, Two-Stage, Food Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of EI-1071 Under Fasted or Fed Conditions in Healthy Volunteers

This is a phase 1, open-label, two-stage, sequential food effect study to evaluate the safety, tolerability, and PK of EI-1071 under fasted or fed conditions in HVs. Approximately 25 evaluable participants will be enrolled in this study, including 11 participants in Stage 1 and 14 participants in Stage 2. Stage 2 study may be conducted based on the results of Stage 1 study.

A Study to Evaluate the Effect of Food on the Bioavailability of AJ201, and Safety, Tolerability, and Pharmacokinetics of AJ201 in Japanese and White Healthy Male Participants

This is a Phase 1, randomized, single-dose, open-label, two-way crossover study to evaluate the effect of food on AJ201, and to evaluate the safety, tolerability, and pharmacokinetics of AJ201 in Japanese and White healthy male participants.

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

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.