PK Study of YH22189 FDC Compared to Combination of Telmisartan/Amlodipine and Rosuvastatin

Study Overview
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Brief Summary
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This is a Randomized, open-label, single-dose, 3-treatment, 3-period, 3-sequence crossover design.

Detailed Description
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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.

Official Title
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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

Conditions
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Hypertension, Hyperlipidemia

Intervention / Treatment
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* Drug: YH22189
* Drug: Twynsta 80/10mg
* Drug: Crestor 20mg


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YH22189<br>YH22189 FDC tablet of Yuhan Corporation | Drug: YH22189<br> <br> |
| Active Comparator: Twynsta 80/10mg<br>Telmisartan/Amlodipine 80/10mg (FDC) | Drug: Twynsta 80/10mg<br> <br> * Other names: Telmisartan/Amlodipine 80/10mg(FDC);|
| Active Comparator: Crestor 20mg<br>Rosuvastatin 20mg | Drug: Crestor 20mg<br> <br> * Other names: Rosuvastatin 20mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Telmisartan Cmax |  | 0 - 72 hrs | 
| Telmisartan AUClast |  | 0 - 72 hrs | 
| Amlodipine Cmax |  | 0 - 168 hrs | 
| Amlodipine AUClast |  | 0 - 168 hrs | 
| Rosuvastatin Cmax |  | 0 - 48 hrs | 
| Rosuvastatin AUClast |  | 0 - 48 hrs |