Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02504606

Enrollment

Registered

2015-07-22

Start date

2014-09-30

Completion date

2014-10-31

Last updated

2015-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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.

Interventions

DRUGBesylsartan

Amlodipin besylate 6.944mg+Losartan K 100mg

DRUGAmosartan

Amlodipin besylate 7.841mg+Losartan K 100mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026