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

NCT01831479 | Completed Phase 1

• 1 other identifier: DWJ1276001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Pharmacokinetics, drug-drug interaction

Outcome Measures

Primary Outcomes (1)

• Profile of Pharmacokinetics

  Css,max, AUCtau

  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

Secondary Outcomes (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

Study Arms (1)

Rosuvastatin and Olmesartan

EXPERIMENTAL

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; Drug: Olmesartan; Drug: Rosuvastatin and olmesartan

Interventions

Rosuvastatin DRUG

Single administration of rosuvastatin 20mg tablet QD for 7 consecutive days

Rosuvastatin and Olmesartan

Olmesartan DRUG

Single administration of olmesartan 40mg tablet QD for 7 consecutive days

Rosuvastatin and Olmesartan

Rosuvastatin and olmesartan DRUG

Co-administration of rosuvastatin 20mg tablet and and olmesartan 40mg tablet QD for 7 consecutive days

Rosuvastatin and Olmesartan

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Severance Hospital: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Rosuvastatin Calcium; olmesartan

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 24, 2013
• First Posted: April 15, 2013
• Study Start: August 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 15, 2013

Record last verified: 2013-04

Locations

KR (1)