Bioequivalence of olmesartan medoxomil versus hydrochlorothiazide in Korean subjects

Completed

• Conditions: Healthy Subjects; Not Applicable

• Registration Number: ISRCTN18353234
• Lead Sponsor: Pacific Pharma Corporation (Korea, South)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-08
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified