Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Besylsartan

Drug

Amlodipin besylate 6.944mg+Losartan K 100mg

Amosartan

Drug

Amlodipin besylate 7.841mg+Losartan K 100mg

Primary outcomes

Change from baseline in blood concentration of Amlodipine

Time frame: 144 hour

Detect the change of blood concentration of Amlodipine by LC-MS/MS
Change from baseline in blood concentration of Losartan

Time frame: 10 hour

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

Sponsors and collaborators

Lead sponsor

Huons Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open-label, Single Dose, 2-Treatment, 2-Period, 2-Way Crossover Study to Assess Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Jul 22, 2015
Registry last updated: Jul 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed