Back to resultsPK Study of YH22189 FDC Compared to Combination of Telmisartan/Amlodipine and Rosuvastatin
Primary Purpose
Hypertension, Hyperlipidemia
Status
Terminated
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YH22189
Twynsta 80/10mg
Crestor 20mg
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
- Who has not suffered from clinically significant disease
- Provision of signed written informed consent
Exclusion Criteria:
- History of and clinically significant disease
- A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
- Administration of other investigational products within 3 months prior to the first dosing
- Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs
- Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 60 (mmHg)
Sites / Locations
- Chonbuk National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
YH22189
Twynsta 80/10mg
Crestor 20mg
Arm Description
YH22189 FDC tablet of Yuhan Corporation
Telmisartan/Amlodipine 80/10mg (FDC)
Rosuvastatin 20mg
Outcomes
Primary Outcome Measures
Telmisartan Cmax
Telmisartan AUClast
Amlodipine Cmax
Amlodipine AUClast
Rosuvastatin Cmax
Rosuvastatin AUClast
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02608242
Brief Title
PK Study of YH22189 FDC Compared to Combination of Telmisartan/Amlodipine and Rosuvastatin
Official Title
A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22189 in Comparison to Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
sponsor decision
Study Start Date
November 2015 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Randomized, open-label, single-dose, 3-treatment, 3-period, 3-sequence crossover design.
Detailed Description
This is a 6 by 3 cross-over study to evaluate pharmacokinetics of YH22189 FDC compared to reference telmisartan/amlodipine and rosuvastatin co-administered in three groups enrolling healthy adult male subjects under fasting conditions.
Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of YH22189 FDC or telmisartan/amlodipine or rosuvastatin administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time. The three treatment periods will be separated by a washout period.
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
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
YH22189
Arm Type
Experimental
Arm Description
YH22189 FDC tablet of Yuhan Corporation
Arm Title
Twynsta 80/10mg
Arm Type
Active Comparator
Arm Description
Telmisartan/Amlodipine 80/10mg (FDC)
Arm Title
Crestor 20mg
Arm Type
Active Comparator
Arm Description
Rosuvastatin 20mg
Intervention Type
Drug
Intervention Name(s)
YH22189
Intervention Type
Drug
Intervention Name(s)
Twynsta 80/10mg
Other Intervention Name(s)
Telmisartan/Amlodipine 80/10mg(FDC)
Intervention Type
Drug
Intervention Name(s)
Crestor 20mg
Other Intervention Name(s)
Rosuvastatin 20mg
Primary Outcome Measure Information:
Title
Telmisartan Cmax
Time Frame
0 - 72 hrs
Title
Telmisartan AUClast
Time Frame
0 - 72 hrs
Title
Amlodipine Cmax
Time Frame
0 - 168 hrs
Title
Amlodipine AUClast
Time Frame
0 - 168 hrs
Title
Rosuvastatin Cmax
Time Frame
0 - 48 hrs
Title
Rosuvastatin AUClast
Time Frame
0 - 48 hrs
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:
Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
Who has not suffered from clinically significant disease
Provision of signed written informed consent
Exclusion Criteria:
History of and clinically significant disease
A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
Administration of other investigational products within 3 months prior to the first dosing
Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs
Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 60 (mmHg)
Facility Information:
Facility Name
Chonbuk National University Hospital
City
Chunju
ZIP/Postal Code
561-712
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PK Study of YH22189 FDC Compared to Combination of Telmisartan/Amlodipine and Rosuvastatin
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