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Keep this study
Lead
Yuhan Corporation
This is a 2 by 2 cross-over study to evaluate pharmacokinetics of YH22162 FDC compared to reference twynsta and Hygroton co-administered in two groups enrolling healthy adult male subjects under fasting conditions.
Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of YH22162 FDC or twynsta and Hygroton co-administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time. The two treatment periods will be separated by a washout period.
Age
19–50
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
1. Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
2. Who has not suffered from clinically significant disease
3. Provision of signed written informed consent
You may not be if
1. History of and clinically significant disease
2. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
3. Administration of other investigational products within 3 months prior to the first dosing.
5. Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 60 (mmHg)
