Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers

Study Overview
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Brief Summary
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This is a phase 1, randomized, open label, single-dose, replicate crossover clinical trial to compare the safety and pharmacokinetics of YH22162 in healthy male volunteers. Hypothesis: Study drug and comparator drug are showing equal pharmacokinetics.

Detailed Description
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In ARM1, 32 subjects will be assigned and the subjects will be administered comparator drug at Day1/Day43 and study drug at Day22/64. In ARM2, 32 subjects will be assigned and the subjects will be administered study drug at Day1/Day43 and comparator drug at Day22/64.

Official Title
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A Randomized, Open-label, Single Dose, Replicate Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg
* Drug: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2 Who has not suffered from clinically significant disease Provision of signed written informed consent Exclusion Criteria: History of and clinically significant disease Administration of other investigational products within 3 months prior to the first dosing Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 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
Interventional Model Description: Randomized, open-label, single-dose, 2-treatment, 2-sequence, 4-period replicate crossover design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM1<br>In ARM1, 32 subjects will be assigned and the subjects will be administered comparator drug at Day1/Day43 and study drug at Day22/64. | Drug: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg<br>* White colored oval three-layer tablet<br>* Other names: Study drug;Drug: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg<br>* White and pink colored oval two-layer tablet<br>* Other names: Comparator drug;|
| Experimental: ARM2<br>In ARM2, 32 subjects will be assigned and the subjects will be administered study drug at Day1/Day43 and comparator drug at Day22/64. | Drug: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg<br>* White colored oval three-layer tablet<br>* Other names: Study drug;Drug: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg<br>* White and pink colored oval two-layer tablet<br>* Other names: Comparator drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast of Telmisartan/amlodipine/chlorthalidone | AUClast | 0-168 hrs | 
| Cmax of Telmisartan/amlodipine/chlorthalidone | Cmax | 0-168 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of Telmisartan/amlodipine/chlorthalidone | AUCinf | 0-168 hrs | 
| Tmax of Telmisartan/amlodipine/chlorthalidone | Tmax | 0-168 hrs | 
| t1/2 of Telmisartan/amlodipine/chlorthalidone | t1/2 | 0-168 hrs |