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

Korea United Pharm

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Amosartan 5/50

Drug: UI15AML055MT

Study type

Interventional

Funder types

Industry

Identifiers

NCT02166398

KUP-UNSD-101

Details and patient eligibility

About

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

Full description

Enrollment

46 estimated patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy 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