Back to resultsA Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet
Primary Purpose
Hypertension, Hyperlipidemia
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fimasartan/Atorvastatin Combination Tablet
Fimasartan
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility 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
Sites / Locations
- Inje University Busan Paik Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group 1
Group 2
Arm Description
Subjects of Group 1 take Fimasartan and Atorvastatin Individual Tablets at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 1 take a Fimasartan/Atorvastatin Combination Tablet at 8th day.
Subjects of Group 2 take a Fimasartan/Atorvastatin Combination Tablet at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 2 take Fimasartan and Atorvastatin Individual Tablets at 8th day.
Outcomes
Primary Outcome Measures
Maximum observed concentration(Cmax) of Fimasartan and Atorvastatin
Area under the curve(AUCt) of Fimasartan and Atorvastatin
Secondary Outcome Measures
Full Information
NCT ID
NCT02566187
First Posted
September 30, 2015
Last Updated
February 23, 2016
Sponsor
Boryung Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02566187
Brief Title
A Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (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
A phase I, Open-label, Randomized, Single-dose, 2 x 2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet and Coadministration of Fimasartan and Atorvastatin as Individual Tablets in Healthy Male Volunteers.
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
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Other
Arm Description
Subjects of Group 1 take Fimasartan and Atorvastatin Individual Tablets at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 1 take a Fimasartan/Atorvastatin Combination Tablet at 8th day.
Arm Title
Group 2
Arm Type
Other
Arm Description
Subjects of Group 2 take a Fimasartan/Atorvastatin Combination Tablet at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 2 take Fimasartan and Atorvastatin Individual Tablets at 8th day.
Intervention Type
Drug
Intervention Name(s)
Fimasartan/Atorvastatin Combination Tablet
Intervention Type
Drug
Intervention Name(s)
Fimasartan
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Primary Outcome Measure Information:
Title
Maximum observed concentration(Cmax) of Fimasartan and Atorvastatin
Time Frame
0~48 hour after medication
Title
Area under the curve(AUCt) of Fimasartan and Atorvastatin
Time Frame
0~48 hour 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 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
Facility Information:
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet
We'll reach out to this number within 24 hrs