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

• Sponsor: Severance Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01831479
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arm: 1
• Duration (Months): 2
• Patients Per Site Per Month: 18

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Rosuvastatin; Drug: Olmesartan; Drug: Rosuvastatin and olmesartan	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rosuvastatin and Olmesartan A multiple-dose administration of rosuvastatin, a multiple-dose administration of olmesartan, and a multiple-dose administration of rosuvastatin and olmesartan, given orally with a washout period of 8 days between each administrations	Drug: Rosuvastatin; Single administration of rosuvastatin 20mg tablet QD for 7 consecutive days; Drug: Olmesartan; Single administration of olmesartan 40mg tablet QD for 7 consecutive days; Drug: Rosuvastatin and olmesartan; Co-administration of rosuvastatin 20mg tablet and and olmesartan 40mg tablet QD for 7 consecutive days

Outcome Measures

Primary Outcome Measures

1. Profile of Pharmacokinetics [0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose with a sample at 72 hr being taken for rosuvastatin only]

   Css,max, AUCtau

Secondary Outcome Measures

1. Profile of Pharmacokinetics [0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose with a sample at 72 hr being taken for rosuvastatin only]

   AUCss,last, AUCss,inf, Css,min, T_1/2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kyungsoo Park, Associate Professor, Severance Hospital
• ClinicalTrials.gov Identifier: NCT01831479
• Other Study ID Numbers: DWJ1276001
• First Posted: Apr 15, 2013
• Last Update Posted: Apr 15, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by Kyungsoo Park, Associate Professor, Severance Hospital: Pharmacokinetics, drug-drug interaction
• Additional relevant MeSH terms: Olmesartan; Olmesartan Medoxomil; Rosuvastatin Calcium

Study Results

No Results Posted as of Apr 15, 2013