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Trial record 84 of 135 for:    OLMESARTAN

Safety and Pharmacokinetic Comparison of Co-administration and a Combination Drug of Rosuvastatin and Olmesartan in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT01823900
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : April 11, 2013
Sponsor:
Information provided by (Responsible Party):
Kyungsoo Park, Severance Hospital

Brief Summary:
This study investigates safety and pharmacokinetic comparison of DWJ1276, a combination drug of Rosuvastatin and Olmesartan (test formulation), and co-administration of Rosuvastatin and Olmesartan (reference formulation) for single dose in healthy volunteers

Condition or disease Intervention/treatment Phase
Healthy Drug: Test formulation Drug: Reference formulation Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Single-Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276 in Healthy Male Volunteers
Study Start Date : January 2012
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2012

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Arm Intervention/treatment
Experimental: Test and reference formulations
Test formulation and reference formulation given orally 7 days apart in a fasted state
Drug: Test formulation
Single administration of a combination tablet of Rosuvastatin 20mg and Olmesartan 40mg

Drug: Reference formulation
Co-administration of Rosuvastatin 20mg tablet and Olmesartan 40mg tablet




Primary Outcome Measures :
  1. Profile of Pharmacokinetics [ Time Frame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose ]
    Cmax, Area Under Curve (0 to last sampling time)


Secondary Outcome Measures :
  1. Profile of Pharmacokinetics [ Time Frame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose ]
    Tmax, Area Under Curve (0 to infinity), 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): NCT01823900


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kyungsoo Park, Associate Professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT01823900     History of Changes
Other Study ID Numbers: DWJ1276
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013
Keywords provided by Kyungsoo Park, Severance Hospital:
Pharmacokinetics
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