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

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ClinicalTrials.gov Identifier: NCT01831479
Recruitment Status : Completed
First Posted : April 15, 2013
Last Update Posted : April 15, 2013
Sponsor:
Information provided by (Responsible Party):
Kyungsoo Park, Severance Hospital

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

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




Primary Outcome Measures :
  1. Profile of Pharmacokinetics [ Time Frame: 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 [ Time Frame: 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



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831479


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Severance Hospital

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Responsible Party: Kyungsoo Park, Associate Professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT01831479     History of Changes
Other Study ID Numbers: DWJ1276001
First Posted: April 15, 2013    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: April 2013
Keywords provided by Kyungsoo Park, Severance Hospital:
Pharmacokinetics, drug-drug interaction
Additional relevant MeSH terms:
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Olmesartan
Olmesartan Medoxomil
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists