An Exploratory Clinical Trial to Evaluate and Compare Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers

DW_DWJ1464103

This study aims to Evaluate and Compare Safety and Pharmacokinetic Characteristics after Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers.

2022-01-27

2023-01-30

2023-01-30

Completed

Early phase I

44

Inclusion Criteria: * Healthy adult volunteers aged 19 years old to under 55. * BMI 18.0≥ and ≤30 kg/m² with body mass ≥50 kg * Those who have no congenital or chronic disease requiring treatment and have no pathological symptoms or findings as a result of medical examination. * Those who have no clinically significant abnormalities in general physical examination, laboratory assessments and 12-lead electrocardiogram (ECG). * Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study. Exclusion Criteria: * Known history or presence of any clinically significant medical condition. Participation in a clinical drug study or bioequivalence study 6 months prior to the present study. * Refusal to abstain from smoking or consumption of tobacco products 72 hours before drug administration and during each study period. * Refusal to abstain from caffeine or grapefruit containing food or drinks for 72 hours before drug administration and during each study period. * Refusal to abstain from strenuous activities for 72 hours before drug administration and post-study visit, before and during each study period.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '4 by 3 cross-over study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 44, 'type': 'ACTUAL'}}

2023-04-27