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A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin

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: NCT02569814
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd

Brief Summary:
A Open-label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin versus Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects.

Condition or disease Intervention/treatment Phase
Hypertension Hyperlipidemia Drug: Fimasartan/Amlodipine/Rosuvastatin Drug: Fimasartan/Amlodipine Drug: Rosuvastatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Group 1
Subjects of Group 1 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 1 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 15th day.
Drug: Fimasartan/Amlodipine/Rosuvastatin
Drug: Fimasartan/Amlodipine
Drug: Rosuvastatin
Group 2
Subjects of Group 2 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 2 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 15th day.
Drug: Fimasartan/Amlodipine/Rosuvastatin
Drug: Fimasartan/Amlodipine
Drug: Rosuvastatin



Primary Outcome Measures :
  1. Cmax of Fimasartan, Amlodipine and Rosuvastatin [ Time Frame: 0~144 hour after medication ]
  2. AUCt(Area Under the Curve) of Fimasartan, Amlodipine and Rosuvastatin [ Time Frame: 0~144 hour after medication ]


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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • a Healthy male subject, aged 19- 50 years

Exclusion Criteria:

  • History of clinically significant hypersensitivity to study drug, any other drug
  • Hypotension or hypertension
  • Active liver disease
  • History of gastrointestinal disease
  • History of excessive alcohol abuse
  • Participation in any other study within 3 months

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): NCT02569814


Locations
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Korea, Republic of
Inje University Busan Paik Hospital
Busan, Korea, Republic of
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
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Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT02569814    
Other Study ID Numbers: BR-FARC-CT-102
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine
Rosuvastatin Calcium
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors