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
|