Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject

Huons Co., Ltd.60 enrolled

Overview

This clinical trial was evaluated to compare the safety and pharmacokinetics of Besylsartan with Amosartan, which was available commercially after single oral dose in healthy male subjects.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

BesylsartanDRUG

Amlodipin besylate 6.944mg+Losartan K 100mg

AmosartanDRUG

Amlodipin besylate 7.841mg+Losartan K 100mg

Eligibility

Sex: MALEMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Body Mass Index (BMI) between 18 and 30 * Healthy as determined by a responsible physician Exclusion Criteria: * History of clinically significant disease * Any chronic disease * Creatine clearance less than 50ml/min * Hypotension (100mmHg/60mmHg) * Treatment of barbital type drug within 1 month * Administration of herbal medicine within 7 days

Outcomes

Primary Outcomes

Change from baseline in blood concentration of Amlodipine

Detect the change of blood concentration of Amlodipine by LC-MS/MS

Time frame: 144 hour

Change from baseline in blood concentration of Losartan

Detect the change of blood concentration of Losartan by LC-MS/MS

Time frame: 10 hour

Data from ClinicalTrials.gov

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