Overview
The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults.
Description
The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults with fasting state: Randomized, open-label, oral, single-dose, four-treatment, three-period, non-replicated crossover study
Eligibility
Inclusion Criteria:
- Healthy adult volunteers aged 19 years old to under 55.
- BMI 18.0 and 30 kg/m 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 alcohol, caffeine, or other xanthines, 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.