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Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject

Last Updated: 2015-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Besylsartan

amlodipine besylate 6.944mg+losartan K 100mg

Group Type EXPERIMENTAL

Besylsartan

Intervention Type DRUG

Amlodipin besylate 6.944mg+Losartan K 100mg

Amosartan

amlodipine besylate 7.841mg+losartan K 100mg

Group Type ACTIVE_COMPARATOR

Amosartan

Intervention Type DRUG

Amlodipin besylate 7.841mg+Losartan K 100mg

Interventions

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Besylsartan

Amlodipin besylate 6.944mg+Losartan K 100mg

Intervention Type DRUG

Amosartan

Amlodipin besylate 7.841mg+Losartan K 100mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes