Clinical Trial to Evaluate the Bioavailability and Safety of AGSAV301

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the bioavailability and safety of AGSAV301 tablet in healthy male volunteers.

Official Title
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A Single Dose, Randomized, Open-label, 2x2 Crossover Study to Evaluate the Bioavailability and Safety of AGSAV301 Tablet in Healthy Male Volunteers

Conditions
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Hypertension

Intervention / Treatment
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* Drug: AGSAV301
* Drug: Exforge 10/160


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult males 20 to 40 years at screening. body weight ≥ 45kg and within ± 20% of the ideal body weight : Ideal body weight = (height [cm] - 100) x 0.9 Be able to collect blood for study and visit for follow-up period Subject who agrees to participate in this study and give written informed consent Exclusion Criteria: Have history of significant hepatic, renal, gastrointestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hematologic, cardiovascular diseases Have a gastrointestinal disease(ex : Crohn's disease, gastrointestinal ulcer)or surgery(except for Appendectomy, Hernia repair) affected the absorption of medications Inappropriate in Screening test (interview, vital sigh, BP, 12-lead ECG, laboratory test etc.) Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of amlodipine or valsartan drug abuse, or have a history of drug abuse showed a positive for the screening test on urine : amphetamine, barbiturate, cocaine, opiates, benzodiazepines, cannabinoids, methadone etc. Subject who takes herbal medicine within 30 days, ethical drug within 14 days, OTC within 7 days before the beginning of administration of investigational drug Unusual diet affected the absorption, distribution, metabolism, excretion of medications Subject who treated with any investigational drugs within 60 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 takes inhibitors and inducers of drug metabolizing enzyme (Barbiturates etc.) within 30days Subject who have taken habitually caffeine (caffeine > 5 units/day) Subject who have drunken habitually (alcohol > 21 units/week, 1 unit = pure alcohol 10ml)or who are unable to quit drinking during this study or smoker positive for Hepatitis B, Hepatitis C, HIV or Syphilis Blood Pressure is not in the range of 140 > sitting SBP ≥ 90mmHg, 90 > sitting DBP ≥ 60mmHg Pulse rate is not in the range of 95 > sitting Pulse Rate ≥ 45bpm (beats per minute) AST, ALT, total bilirubin over twice of reference range Subjects deemed ineligible by investigator based on other reasons

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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: AGSAV301<br> | Drug: AGSAV301<br>* tablet, q.d.<br>|
| Active Comparator: Exforge 10/160<br> | Drug: Exforge 10/160<br>* Tablet, q.d.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve (AUC) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120, 168 hours | 
| Cmax |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120,168 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (inf) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120,168 hours | 
| tmax |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120, 168 hours | 
| t(1/2β) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120, 168 hours |