Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject
Phase 1
Completed
- Conditions
- Hypertension
- Interventions
- Drug: BesylsartanDrug: Amosartan
- Registration Number
- NCT02504606
- Lead Sponsor
- Huons Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
Inclusion Criteria
- Body Mass Index (BMI) between 18 and 30
- Healthy as determined by a responsible physician
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Besylsartan Besylsartan amlodipine besylate 6.944mg+losartan K 100mg Amosartan Amosartan amlodipine besylate 7.841mg+losartan K 100mg
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method