A Phase Ⅰa Study of Azilsartan Trimethylethanolamine in Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the Pharmacokinetics and safety of Azilsartan Trimethylethanolamine in healthy volunteers

Official Title
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A Placebo-Controlled, Phase I, Single-center Evaluation of the Single-dose Pharmacokinetics Study of Azilsartan Trimethylethanolamine

Conditions
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Health

Intervention / Treatment
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* Drug: Azilsartan Trimethylethanolamine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males or females Aged from 18 years to 45 years Body mass index (BMI) 19 to 25kg/m2 Exclusion Criteria: Has a known sensitivity to angiotensin II receptor blocker（ARB） With evidence of uncontrolled renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction, in the opinion of the investigator or medical monitor Has known or suspected history of alcoholism or drug abuse or misuse With a history of laboratory results that show the presence of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV) Pregnant,lactating，menstrual Vegetarian Postural hypotension Systolic blood pressure<100mmHg，or>130mmHg;and/or diastolic blood pressure<70mmHg,or>90mmHg

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.Azilsartan Trimethylethanolamine<br>Single dose of Azilsartan Trimethylethanolamine with 8.75mg,orally | Drug: Azilsartan Trimethylethanolamine<br> <br> |
| Experimental: 2.Azilsartan Trimethylethanolamine<br>Single dose of Azilsartan Trimethylethanolamine with 17.5mg,orally | Drug: Azilsartan Trimethylethanolamine<br> <br> |
| Experimental: 3.Azilsartan Trimethylethanolamine<br>Single dose of Azilsartan Trimethylethanolamine with 35mg,orally | Drug: Azilsartan Trimethylethanolamine<br> <br> |
| Experimental: 4.Azilsartan Trimethylethanolamine<br>Single dose of Azilsartan Trimethylethanolamine with 70mg,orally | Drug: Azilsartan Trimethylethanolamine<br> <br> |
| Experimental: 5.Azilsartan Trimethylethanolamine<br>Single dose of Azilsartan Trimethylethanolamine with 140mg,orally | Drug: Azilsartan Trimethylethanolamine<br> <br> |
| Experimental: 6.Azilsartan Trimethylethanolamine<br>Single dose of Azilsartan Trimethylethanolamine with 210mg,orally | Drug: Azilsartan Trimethylethanolamine<br> <br> |
| Experimental: 7.Azilsartan Trimethylethanolamine<br>Single dose of Azilsartan Trimethylethanolamine with 280mg,orally | Drug: Azilsartan Trimethylethanolamine<br> <br> |
| Placebo Comparator: Placebo<br>Placebo-matching tablets, orally | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the Pharmacokinetics of Azilsartan Trimethylethanolamine by assessment of drug concentration through blood sample analysis |  | Pre-dose to 72 hours post-dosee | 
| Number of participants with adverse reactions | The trial shoud be terminated ，if more than a third of participants had grade 2 or more than 2 adverse reactions based on Common Terminology Criteria for Adverse Events(CTCAE) Version 4.02 | Pre-dose to 72 hours post-dose |