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

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ClinicalTrials.gov Identifier: NCT02704702
Recruitment Status : Completed
First Posted : March 10, 2016
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd

Study Description
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Brief Summary:
The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and rosuvastatin when coadministered or administered alone as a single dose or as multiple doses to healthy male subjects.

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

Detailed Description:
This is an open-label, randomized, 6-sequence, 3-period, 3-way crossover study. Within each period, randomized subjects will be 2 dosing regimens with the same drug(fimasartan or rosuvastatin) or study drug combination(fimasartan+rosuvastatin) on day 1 and quaque die(qd) from day 4 to day 10. After day 1 and day 10 dosing will be followed by pharmacokinetic sampling for 48 hours or 72 hours.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Study Start Date : March 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Sequence 1 (ABC)

Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C)

There will be a washout of at least 7 days between the each period.

 Drug: Fimasartan
Drug: Rosuvastatin
Drug: Fimasartan + Rosuvastatin
Sequence 2 (ACB)

Period 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B)

There will be a washout of at least 7 days between the each period.

 Drug: Fimasartan
Drug: Rosuvastatin
Drug: Fimasartan + Rosuvastatin
Sequence 3 (BAC)

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

There will be a washout of at least 7 days between the each period.

 Drug: Fimasartan
Drug: Rosuvastatin
Drug: Fimasartan + Rosuvastatin
Sequence 4 (BCA)

Period 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A)

There will be a washout of at least 7 days between the each period.

 Drug: Fimasartan
Drug: Rosuvastatin
Drug: Fimasartan + Rosuvastatin
Sequence 5 (CAB)

Period 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B)

There will be a washout of at least 7 days between the each period.

 Drug: Fimasartan
Drug: Rosuvastatin
Drug: Fimasartan + Rosuvastatin
Sequence 6 (CBA)

Period 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A)

There will be a washout of at least 7 days between the each period.

 Drug: Fimasartan
Drug: Rosuvastatin
Drug: Fimasartan + Rosuvastatin


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Concentration-time Curve [ Time Frame: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period ]
    This Outcome is the Area Calculated using the Linear Trapezoidal with Linear Interpolation Method

  2. Maximum Observed Concentration [ Time Frame: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period ]
    This Outcome is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated.

  3. Time to Reach Maximum Observed Plasma Concentration [ Time Frame: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period ]
    This Outcome is the time it takes a drug to reach Cmax


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:

  1. Caucasian male 19-55 years of age.
  2. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 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 90/60 mmHg or greater than 140/90 mmHg at screening.
  4. Plasma donation within 7 days prior to the first dose of study drug.
  5. Participation in another clinical trial within 28 days prior to the first dose of study drug(s).
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): NCT02704702


Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Investigators
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Principal Investigator: Laura Sterling, M.D Celelion, Inc.
More Information
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Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT02704702    
Other Study ID Numbers: BR-FRC-CT-102
CA16652 ( Other Identifier: Celerion )
First Posted: March 10, 2016    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018
Last Verified: February 2018
Keywords provided by Boryung Pharmaceutical Co., Ltd:
Fimasartan
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors