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Pharmacokinetics and Drug Interaction Study Between Amlodipine,Olmesartan and Rosuvastatin in Healthy Adult Volunteers

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ClinicalTrials.gov Identifier: NCT02089399
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between amlodipine, olmesartan and rosuvastatin in healthy adult volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: Sevikar(amlodipne/olmesartan) Drug: crestor(Rosuvastatin) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: An Open Label, Randomized, 2-Sequence, Multiple-Dose, Cross-Over Study to Investigate the Drug-Drug Interaction of Sevikar and Crestor in Healthy Adult Volunteers
Study Start Date : May 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment AB
S->S+C
 Drug: Sevikar(amlodipne/olmesartan)
Treatment AB

Drug: crestor(Rosuvastatin)
Treatment AB/Treatment C
Experimental: Treatment C
C
 Drug: crestor(Rosuvastatin)
Treatment AB/Treatment C


Outcome Measures
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Primary Outcome Measures :
  1. AUCtau [ Time Frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment ]
  2. Css,max [ Time Frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment ]

Secondary Outcome Measures :
  1. Tss,max [ Time Frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment ]
  2. Css,min [ Time Frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects aged 19 - 55 years
  • A body mass index in the range 19 - 27 kg/m2
  • Willingness to participate during the entire study period
  • Written informed consent after being fully informed about the study procedures

Exclusion Criteria:

  • Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
  • History of clinically significant drug hypersensitivity
  • Use of medication within 7 days before the first dose
  • Heavy drinker (>140 g/week)
  • Whole blood donation during 60 days before the study
  • Judged not eligible for study participation by investigator
Contacts and Locations
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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): NCT02089399


Locations
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Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
More Information
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Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT02089399    
Other Study ID Numbers: DW_DWJ1351001
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Olmesartan
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