Back to resultsDP-R212 Pharmacokinetic Study
Primary Purpose
Hypertension, Hyperlipidemias
Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Amlodipine
Rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- BMI 18-29
- signed the informed consent form prior to the study participation
Exclusion Criteria:
- Clinically significant disease
- Previously donate whole blood within 60 days or component blood within 14 days
- Clinically significant allergic disease
- Taken IP in other trial within 90 days
- An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Sites / Locations
- Inha university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
amplodipine group
rosuvastatin group
Arm Description
Amlodipine for 8 days and Amlodipine+Rosuvastatin for 5 days
Rosuvastatin for 5 days and Amlodipine+Rosuvastatin for 8 days
Outcomes
Primary Outcome Measures
AUCτ,ss of Amlodipine and Rosuvastatin
Cmax,ss of Amlodipine and Rosuvastatin
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02789475
Brief Title
DP-R212 Pharmacokinetic Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alvogen Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
An open-label, multiple-dose study to evaluate the pharmacokinetic drug-drug interaction of amlodipine and rosuvastatin in healthy adult male subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hyperlipidemias
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
amplodipine group
Arm Type
Experimental
Arm Description
Amlodipine for 8 days and Amlodipine+Rosuvastatin for 5 days
Arm Title
rosuvastatin group
Arm Type
Experimental
Arm Description
Rosuvastatin for 5 days and Amlodipine+Rosuvastatin for 8 days
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Intervention Description
Amlodipine administration
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
Rosuvastatin administration
Primary Outcome Measure Information:
Title
AUCτ,ss of Amlodipine and Rosuvastatin
Time Frame
0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr
Title
Cmax,ss of Amlodipine and Rosuvastatin
Time Frame
0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI 18-29
signed the informed consent form prior to the study participation
Exclusion Criteria:
Clinically significant disease
Previously donate whole blood within 60 days or component blood within 14 days
Clinically significant allergic disease
Taken IP in other trial within 90 days
An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chul woo Kim, Ph.D.
Phone
82-92-890-1168
Email
cwkim1805@inha.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chul woo Kim, Ph.D.
Organizational Affiliation
Inha University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inha university hospital
City
Jung-gu
State/Province
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chul woo Kim, Ph.D.
Email
cwkim1805@inha.ac.kr
12. IPD Sharing Statement
Plan to Share IPD
No
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DP-R212 Pharmacokinetic Study
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