Back to resultsA Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin
Primary Purpose
Hypertension, Hyperlipidemia
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fimasartan/Amlodipine/Rosuvastatin
Fimasartan/Amlodipine
Rosuvastatin
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/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 1 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 15th day.
Subjects of Group 2 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 2 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 15th day.
Outcomes
Primary Outcome Measures
Cmax of Fimasartan, Amlodipine and Rosuvastatin
AUCt(Area Under the Curve) of Fimasartan, Amlodipine and Rosuvastatin
Secondary Outcome Measures
Full Information
NCT ID
NCT02569814
First Posted
October 5, 2015
Last Updated
February 23, 2016
Sponsor
Boryung Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02569814
Brief Title
A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 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 Open-label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin versus Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects.
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
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Other
Arm Description
Subjects of Group 1 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 1 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 15th day.
Arm Title
Group 2
Arm Type
Other
Arm Description
Subjects of Group 2 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 2 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 15th day.
Intervention Type
Drug
Intervention Name(s)
Fimasartan/Amlodipine/Rosuvastatin
Intervention Type
Drug
Intervention Name(s)
Fimasartan/Amlodipine
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Primary Outcome Measure Information:
Title
Cmax of Fimasartan, Amlodipine and Rosuvastatin
Time Frame
0~144 hour after medication
Title
AUCt(Area Under the Curve) of Fimasartan, Amlodipine and Rosuvastatin
Time Frame
0~144 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 and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin
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