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A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Amlodipine in Healthy Male Subjects

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: NCT02920047
Recruitment Status : Completed
First Posted : September 30, 2016
Last Update Posted : January 9, 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 when administrated Fimasartan/Amlodipine and when co-administrated Fimasartan and Amlodipine.

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

Detailed Description:
This is an open-label, randomized, 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/Amlodipine and co-administration of Fimasartan and Amlodipine.

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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: Other
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/Amlodipine and Co-administration of Fimasartan and Amlodipine in Healthy Male Volunteers
Actual Study Start Date : October 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequence A

Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B)

There will be a washout of 14 days between the each period.

Drug: Fimasartan/Amlodipine
Treatment B

Drug: Fimasartan + Amlodipine
Treatment A

Experimental: Sequence B

Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A)

There will be a washout of 14 days between the each period.

Drug: Fimasartan/Amlodipine
Treatment B

Drug: Fimasartan + Amlodipine
Treatment A

Experimental: Sequency C

Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A)

There will be a washout of 14 days between the each period.

Drug: Fimasartan/Amlodipine
Treatment B

Drug: Fimasartan + Amlodipine
Treatment A




Primary Outcome Measures :
  1. Cmax and AUClast of Fimasartan, Amlodipine [ Time Frame: Time Frame: 0~144 hour 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:

  1. Male 19-50 years of age.
  2. Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening.
  3. Medically healthy with no clinically significant medical history.
  4. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria:

  1. History or presence of clinically significant medical or psychiatric condition or disease.
  2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
  3. Seated blood pressure is less than 100/65 mmHg or greater than 140/90 mmHg at screening.
  4. Plasma donation within a month prior to the first dose of study drug.
  5. Participation in another clinical trial within 3 months prior to the first dose of study drug(s).

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): NCT02920047


Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Investigators
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Principal Investigator: Kyung-Sang Yu, PhD Seoul National University Hospital
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Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT02920047    
Other Study ID Numbers: BR-FAC-CT-102
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Boryung Pharmaceutical Co., Ltd:
Fimasartan
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents