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A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Atorvastatin in Healthy Male 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: NCT02994745
Recruitment Status : Completed
First Posted : December 16, 2016
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd

Brief Summary:
The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of Fimasartan and Atorvastatin in Healthy Male volunteers.

Condition or disease Intervention/treatment Phase
Hypertension, Hyperlipidemia Drug: Fimasartan, Atorvastatin Phase 1

Detailed Description:
This is a randomized, open-label, single dose, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Atorvastatin and co-administration of Fimasartan and Atorvastatin.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between a Fixed Dose Combination of Fimasartan 120mg/Atorvastatin 40mg and Co-administration of Fimasartan 120mg and Atorvastatin 40mg in Healthy Male Volunteers.
Actual Study Start Date : December 23, 2016
Actual Primary Completion Date : February 21, 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A fixed dose combination group
A fixed dose combination of Fimasartan/Atorvastatin
Drug: Fimasartan, Atorvastatin
Active Comparator: Co-administration group
Co-administration of Fimasartan and Atorvastatin
Drug: Fimasartan, Atorvastatin



Primary Outcome Measures :
  1. Cmax(Maximum concentration of drug in plasma) of Fimasartan, Atorvastatin [ Time Frame: 0~48 hours after medication ]
  2. AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Fimasartan, Atorvastatin [ Time Frame: 0~48 hours after medication ]


Information from the National Library of Medicine

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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 aged 19-50 years
  • Body weight is over 55kg and BMI 18 ~ 27(kg/m2).
  • A subject provide written informed consent which he voluntarily confirms willingness to participate in a study, having been informed of the full details of the study and comply with the protocol.
  • A subject who is eligible according to investigator's assessment

Exclusion Criteria:

  • History or presence of clinically significant medical or psychiatric condition or disease.
  • History of gastrointestinal disease and resection
  • Hypersensitivity to ingredient of investigational product(IP) and other medication, food.
  • Genetic Problem such as Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption.
  • A subject who take a drug that inhibit or induce significantly Drug-Metabolizing Enzyme within 1months.
  • Positive results for serum examination(HIV, B and C viral test, Syphilis).
  • Seated BP is less than 100/65 mmHg or greater than 140/90 mmHg at screening.
  • Participation in any other study within 3months.
  • History of whole blood donation within 2months and Apheresis 2 weeks.

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): NCT02994745


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
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Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT02994745    
Other Study ID Numbers: BR-FAVC-CT-102
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors