Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject

July 20, 2015 updated by: Huons Co., Ltd.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Besylsartan
amlodipine besylate 6.944mg+losartan K 100mg
Drug: Besylsartan
Amlodipin besylate 6.944mg+Losartan K 100mg
Active Comparator: Amosartan
amlodipine besylate 7.841mg+losartan K 100mg
Drug: Amosartan
Amlodipin besylate 7.841mg+Losartan K 100mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in blood concentration of Amlodipine
Time Frame: 144 hour
Detect the change of blood concentration of Amlodipine by LC-MS/MS
144 hour
Change from baseline in blood concentration of Losartan
Time Frame: 10 hour
Detect the change of blood concentration of Losartan by LC-MS/MS
10 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huons Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

July 17, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Estimate)

July 22, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HU-009-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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