A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of UI15AML055MT and Amosartan® Tablet 5/50 mg After a Single Oral Administration in Healthy Male Volunteers

Study Overview
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Brief Summary
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A randomized, open-label, single dose, two-way crossover clinical trial to compare the safety, pharmacokinetic profiles of UI15AML055MT and Amosartan® tablet 5/50 mg after a single oral administration in healthy male volunteers

Detailed Description
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A randomized, open-label, single dose, two-way crossover clinical trial to compare the safety, pharmacokinetic profiles of UI15AML055MT and Amosartan® tablet 5/50 mg after a single oral administration in healthy male volunteers

Official Title
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Phase 1 Study of Compare the Safety, Pharmacokinetic Profiles of UI15AML055MT and Amosartan® Tablet 5/50 mg

Conditions
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Healthy

Intervention / Treatment
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* Drug: UI15AML055MT
* Drug: Amosartan 5/50


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 20 under 45 years of age BMI state over 19 under 27 Exclusion Criteria: mean sit SBP≥100mmHg or mean sit DBP≥150mmHg at screening mean sit SBP≥65mmHg or mean sit DBP≥95mmHg at screening Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST) History of alcohol or drug abuse Positive to pregnancy test, nursing mother, has an intention on pregnancy Considered by investigator as not appropriate to participate in the clinical study with othe reason

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 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 |
| --- | --- |
| Active Comparator: Amosartan 5/50 tab<br>Amosartan 5/50 tab given by oral administration | Drug: Amosartan 5/50<br>* tab, PO<br>|
| Experimental: UI15AML055MT tab<br>UI15AML055MT tab given by oral administration | Drug: UI15AML055MT<br>* tab, PO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast of Amlodipine |  | 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose | 
| AUCinf of Amlodipine |  | 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose | 
| Cmax of Amlodipine |  | 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose | 
| AUClast of Losartan |  | 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose | 
| AUCinf of Losartan |  | 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose | 
| Cmax of Losartan |  | 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax of Amlodipine |  | 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose | 
| t1/2 of Amlodipine |  | 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose | 
| CL/F of Amlodipine |  | 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose | 
| Tmax of Losartan |  | 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose | 
| t1/2 of Losartan |  | 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose | 
| CL/F of Losartan |  | 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amlodipine basylate, Losartan potassium