Pharmacokinetic properties and bioequivalence of olmesartan medoxomil versus ydrochlorothiazide in Korean subjects

Pacific Pharma Corporation (Korea, South)0 个研究点目标入组 40 人开始时间: 2012年11月8日最近更新: 2015年1月13日

试验速览

暂无简介。

•1. Healthy subjects aged 19 to 55
•2. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests
•3. Informed consent signed by the subject
•4. Not pregnant female subject

•1. Use of any drugs known to significantly induce or inhibit drug-metabolizing enzymes within 1 month prior to dosing
•2. Use of prescription or nonprescription drugs within 10 days prior to the first dose of study medication
•3. Subjects who are known or suspected not to comply with the study directives
•4. Participating in a bioequivalence study or other clinical study within 3 month preceding the first dose of study medication
•5. Pregnant or nursing females
•6. Subject who are hypersensitive to study medication or other related compounds
•7. History of sensitivity to thiazide diuretics or sulfonamides
•8. Acute or Chronic renal failure (creatinine clearance < 30mL/min), anuric patient
•9. Severe Hepatic failure
•10. Biliary atresia, biliary cirrhosis
•11. Hyponatremia, hypokalemia, hypercalcemia, hyperuricemia patient
•12. Addison's disease patient
•13. Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption

发起方

Pacific Pharma Corporation (Korea, South)