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

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

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

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

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