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Investigation of Pharmacokinetic Interaction Between Rosuvastatin and Olmesartan in Healthy Male Volunteers

Information source: Severance Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Rosuvastatin (Drug); Olmesartan (Drug); Rosuvastatin and olmesartan (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Severance Hospital

Summary

This study investigates pharmacokinetics and drug-drug interaction between Rosuvastatin and Olmesartan in healthy male volunteers

Clinical Details

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Profile of Pharmacokinetics

Secondary outcome: Profile of Pharmacokinetics

Eligibility

Minimum age: 20 Years. Maximum age: 50 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal

body weight, without congenital abnormality or chronic disease Exclusion Criteria:

- History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal,

hematologic, neurologic or hemorrhagic disease;

- Clinically significant findings on routine laboratory (hematology, serum chemistry

and urinalysis) or ECG tests;

- Use of prescription drugs in the 14 days immediately prior to starting the study that

had the potential to interact with the study medication;

- Use of any substance that could induce or inhibit drug metabolism enzymes

Locations and Contacts

Severance Hospital, Seoul 120-752, Korea, Republic of
Additional Information

Starting date: August 2011
Last updated: April 9, 2013

Page last updated: August 20, 2015

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