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. Inc.46 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

UI15AML055MTDRUG

tab, PO

Amosartan 5/50DRUG

tab, PO

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Outcomes

Primary Outcomes

AUClast of Amlodipine

Time frame: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose

AUCinf of Amlodipine

Time frame: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose

Cmax of Amlodipine

Time frame: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose

AUClast of Losartan

Time frame: 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

Time frame: 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

Time frame: 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 Outcomes

Tmax of Amlodipine

Time frame: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose

t1/2 of Amlodipine

Time frame: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose

CL/F of Amlodipine

Time frame: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose

Tmax of Losartan

Time frame: 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

Data from ClinicalTrials.gov

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