Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject

Huons

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: Besylsartan; Drug: Amosartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02504606

HU-009-01

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Besylsartan

Experimental group

Description:

amlodipine besylate 6.944mg+losartan K 100mg

Treatment:

Drug: Besylsartan

Amosartan

Active Comparator group

Description:

amlodipine besylate 7.841mg+losartan K 100mg

Treatment:

Drug: Amosartan