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Keep this study
Lead
Yuhan Corporation
With
Seoul National University Hospital
This clinical trial will be conducted in healthy Korean and Caucasian volunteers at Seoul National University Hospital (SNUH) Clinical Trial Center.
It is expected to take approximately 39 days from the first dosing of Investigational Product until the final follow-up visit. It will be hospitalized twice for 9 nights and 10 days with 21 days of interval, and one visit will be needed for safety evaluation between 14-17 days from the last dosing of the Investigational Product.
Age
19–55
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
1. Informed of the investigational nature of this study and voluntarily agree to participate in this study.
2. Subjects with BMI range of ≥18.5 kg/m2 and \< 30.0 kg/m2 and weighing ≥ 50 kg
3. Subjects without congenital or chronic diseases within the last 3 years and without pathologic symptoms as determined by medical diagnosis
4. Healthy Korean and Caucasian males who aged ≥ 19 and ≤ 55 years at the time of consent
You may not be if
1. Clinically significant chronic infection (e.g. AIDS) or clinically significant medical or psychiatric illness
2. Hypotension (SBP ≤ 90 mmHg or DBP ≤ 50 mmHg) or hypertension (SBP ≥ 150 mmHg or DBP ≥ 100 mmHg)
3. A marked baseline prolongation of QTc greater than 450 msec by Bazett's formula
4. Within 14 days prior to the first administration of investigational product, use of prescription drugs or herbal medication, or within 7 days use of any over-the-counter medications
Clareo Health | Clinical Trial to Evaluate the Safety and Effects of Ethnicity and Food on Pharmacokinetics of YH25448
