Phase I Study to Investigate the Effect on the Blood Pressure After Oral Administration of SK3530 and Amlodipine

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and Amlodipine, phase I study in Hypertensive patient was designed.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SK Chemicals Co., Ltd.; SK Chemicals Co.,Ltd.
• Treatments: Amlodipine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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