Investigate a Pharmacokinetic Characteristics and the Safety of AG1502 in Healthy Male Subjects

Study Overview
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Brief Summary
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Primary object : Evaluate pharmacokinetic property AG1502 and Candesartan 32mg and Atorvastatin 40mg in healthy male subjects.

Conditions
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Healthy Male Subjects

Intervention / Treatment
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* Drug: Atorvastatin + Candesartan
* Drug: AG1502


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult healthy males 19 to 45 years at screening. BMI 18-29 kg/m2 Exclusion Criteria: History of cardiovascular, respiratory, hepatic, renal, neuropsychiatric, endocrine, hematologic disease Hypersensitivity reactions to drugs or significant hypersensitivity reactions in the history of Candesartan and Atorvastatin Hypotension (DBP ≤ 100 mmHg or SBP ≤ 95mmHg) and hypertension (SBP ≥ 150 mmHg or DBP ≥ 95 mmHg) Gastrointestinal disease affected the absorption of medications Genetic disease of Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption AST or ALT > 2 x normal range Total bilirubin > 2.0 mg/dl CK > 2 x normal range eGFR < 60 mL/min/1.73m2 Subject who have drunken habitually (alcohol more than 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) or who are unable to quit drinking during this study Subject who have smoke habitually more than 10 cigarettes/day or who are unable to quit smoking during this study Subject who treated with any investigational drugs within 90 days before the administration of investigational drug Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days Subject who treated with any drug within 30 days can affect absorption, distribution, metabolism, excretion of candesartan or atorvastatin Subject who treated with any Rx only drug or herbal drug within 14 days and any OTC within 7 days History of drug abuse Genetic neuromuscular disorder or family history of neuromuscular disorder Unusual diet affected the absorption, distribution, metabolism, excretion of medications Subjects deemed ineligible by investigator based on other reasons

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

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 |
| --- | --- |
| Experimental: AG1502<br> | Drug: Atorvastatin + Candesartan<br> <br> Drug: AG1502<br> <br> |
| Active Comparator: Candesartan + Atorvastatin<br> | Drug: Atorvastatin + Candesartan<br> <br> Drug: AG1502<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (candesartan cilexetil) |  | 0,0.5,1,2,3,4,5,6,8,10,12,24,48 hours | 
| AUClast (candesartan cilexetil) |  | 0,0.5,1,2,3,4,5,6,8,10,12,24,48 hours | 
| Cmax (Atorvastatin) |  | 0,0.25,0.5,0.75,1,1.333,1.667,2,3,4,6,8,12,24,48 hours | 
| AUClast (Atorvastatin) |  | 0,0.25,0.5,0.75,1,1.333,1.667,2,3,4,6,8,12,24,48 hours |