PK Study of YH22162 FDC Compared to Combination of Twynsta and Hygroton

Study Overview
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Brief Summary
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This is a Randomized, open-label, single-dose, 2-treatment, 2-period, 2-sequence crossover design.

Detailed Description
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This is a 2 by 2 cross-over study to evaluate pharmacokinetics of YH22162 FDC compared to reference twynsta and Hygroton co-administered in two 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 YH22162 FDC or twynsta and Hygroton co-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 two 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 YH22162 in Comparison to the Co-administration of Twynsta and Hygroton in Healthy Volunteers

Conditions
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Hypertension

Intervention / Treatment
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* Drug: YH22162
* Drug: Telmisartan/Amlodipine 80/5 mg (FDC)
* Drug: Chlorthalidone 25mg


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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 - Period 1<br>Telmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg | Drug: Telmisartan/Amlodipine 80/5 mg (FDC)<br> <br> * Other names: Twinstar 80/5 mg;Drug: Chlorthalidone 25mg<br> <br> * Other names: Hygroton 25mg;|
| Experimental: Group 2 - Period 1<br>YH22162 FDC tablet of Yuhan Corporation | Drug: YH22162<br> <br> |
| Experimental: Group 1 - Period 2<br>YH22162 FDC tablet of Yuhan Corporation | Drug: YH22162<br> <br> |
| Active Comparator: Group 2 - Period 2<br>Telmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg | Drug: Telmisartan/Amlodipine 80/5 mg (FDC)<br> <br> * Other names: Twinstar 80/5 mg;Drug: Chlorthalidone 25mg<br> <br> * Other names: Hygroton 25mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence study is based on Cmax and AUC parameters |  | 1 month |