Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 91 of 134 for:    OLMESARTAN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

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

Layout table for study information
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

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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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
Layout table for location information
Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.

Layout table for additonal information
Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT02089399     History of Changes
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:
Layout table for MeSH terms
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