Safety and Pharmacokinetics Study of Amlodipine 10mg and Candesartan 32mg

Launched by SHIN POONG PHARMACEUTICAL CO. LTD. · Aug 20, 2013

Keywords

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Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Male volunteers in the age between 20 and 55 years old(inclusive).
• • 2. Body weight \>= 55kg and Body mass index (BMI) in the range of calculated IBW ±20%.
• • 3. Subjects without a hereditary problems or chronic desease.
• • 4. Subjects whose clinical laboratory test values are inside the accepted normal range.
• • 5. Understand the requirements of the study and voluntarily consent to participate in the study.
• Exclusion Criteria:
• • 1. Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines.
• • 2. Systolic blood pressure range ≥150 mmHg or ≤ 100 mmHg or diastolic blood pressure range ≥ 95 mmHg or ≤ 60 mmHg.
• • 3. Subject with symptoms of acute disease within 14days prior to study medication dosing.
• • 4. Subjects with a history of clinically significant allergies of amlodipin or candesartan or CCB or other medicine (ex. aspirin or antibiotics).
• • 5. Subjects with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
• • 6. Serum creatinine \> 1.2mg/dL.
• • 7. smoking \> 10 cigarettes/day.
• • 8. alcohol \> 210g/week.
• • 9. Positive test results for drug test in urin or subject with history of substance abuse.
• • 10. Participation in any clinical investigation within 2 months prior to study medication dosing.
• • 11. Subjects with whole blood donation within 2 months, component blood donation within 1 month and blood transfusion within 1 month prior to study medication dosing.
• • 12. Subjects considered as unsuitable based on medical judgement by investigators.