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

SK chemicals

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: SK3530 100mg, Placebo, Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00626743

SK3530_AMD_I_2007

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: Male

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups, including a placebo group

SK3530

Experimental group

Description:

Active Drug

Treatment:

Drug: SK3530 100mg, Placebo, Amlodipine

Placebo

Placebo Comparator group

Description:

Tablet which has the same appearance and taste but doesn't contain active ingredient

Treatment:

Drug: SK3530 100mg, Placebo, Amlodipine