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A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Atorvastatin in Healthy Male Volunteers.

Primary Purpose

Hypertension, Hyperlipidemia

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fimasartan, Atorvastatin
Sponsored by
Boryung Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Hyperlipidemia

Eligibility Criteria

19 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A fixed dose combination group

Co-administration group

Arm Description

A fixed dose combination of Fimasartan/Atorvastatin

Co-administration of Fimasartan and Atorvastatin

Outcomes

Primary Outcome Measures

Cmax(Maximum concentration of drug in plasma) of Fimasartan, Atorvastatin
AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Fimasartan, Atorvastatin

Secondary Outcome Measures

Full Information

First Posted
December 1, 2016
Last Updated
January 16, 2018
Sponsor
Boryung Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02994745
Brief Title
A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Atorvastatin in Healthy Male Volunteers.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 23, 2016 (Actual)
Primary Completion Date
February 21, 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boryung Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A fixed dose combination group
Arm Type
Experimental
Arm Description
A fixed dose combination of Fimasartan/Atorvastatin
Arm Title
Co-administration group
Arm Type
Active Comparator
Arm Description
Co-administration of Fimasartan and Atorvastatin
Intervention Type
Drug
Intervention Name(s)
Fimasartan, Atorvastatin
Primary Outcome Measure Information:
Title
Cmax(Maximum concentration of drug in plasma) of Fimasartan, Atorvastatin
Time Frame
0~48 hours after medication
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Atorvastatin in Healthy Male Volunteers.

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