Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
SK Chemicals Co., Ltd.
Age
19–65
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Male subjects 19-65 years of age inclusive
Subjects with hypertension as defined 100 mmHg ≤ SBP\<140 mmHg and 65 mmHg ≤ DBP \< 90 mmHg after more than 5 minutes in the supine position
Written informed consent
Willing and able to comply with the requirements of the protocol
You may not be if
Subjects with acute or chronic disease within 4 weeks of study initiation.
Subejcts with any gastrointestinal disorders known to alter drug absorption(except appendectomy, herniotomy, etc.)
Subjects with any clinically significant allergic disease or with a known allergy to the PDE5 inhibitors
Subjects with clinically significant abnormalities on laboratory tests
Subjects with orthostatic hypotension defined as a fall in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg when a person assumes a standing position
Subjects with abnormal QTc interval(≥440ms)
Subjects with color-blindness or weakness
Subejcts with alcohol, drug or caffeine abuse
Diet known to alter drug absorption, distribution, metabolism or elimination processes
Subjects who participated in other clinical studies within 2 months before an administration
Other subjects who are ineligible for the study at the discretion of the principle investigator or sub-investigators
Clareo Health | Phase I Study to Investigate the Effect on the Blood Pressure After Oral Administration of SK3530 and Amlodipine
