A Phase Ⅰa Study of Azilsartan Trimethylethanolamine in Healthy Volunteers

Phase 1

• Conditions: Health
• Interventions: Drug: Azilsartan Trimethylethanolamine; Drug: Placebo

• Registration Number: NCT01985152
• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-31
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-07
• Last Update Submitted: 2013-11-07
• Study First Posted: 2013-11-15
• Last Update Posted: 2013-11-15
• Primary Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2.Azilsartan Trimethylethanolamine	Azilsartan Trimethylethanolamine	Single dose of Azilsartan Trimethylethanolamine with 17.5mg,orally
3.Azilsartan Trimethylethanolamine	Azilsartan Trimethylethanolamine	Single dose of Azilsartan Trimethylethanolamine with 35mg,orally
5.Azilsartan Trimethylethanolamine	Azilsartan Trimethylethanolamine	Single dose of Azilsartan Trimethylethanolamine with 140mg,orally
6.Azilsartan Trimethylethanolamine	Azilsartan Trimethylethanolamine	Single dose of Azilsartan Trimethylethanolamine with 210mg,orally
Placebo	Placebo	Placebo-matching tablets, orally
1.Azilsartan Trimethylethanolamine	Azilsartan Trimethylethanolamine	Single dose of Azilsartan Trimethylethanolamine with 8.75mg,orally
4.Azilsartan Trimethylethanolamine	Azilsartan Trimethylethanolamine	Single dose of Azilsartan Trimethylethanolamine with 70mg,orally
7.Azilsartan Trimethylethanolamine	Azilsartan Trimethylethanolamine	Single dose of Azilsartan Trimethylethanolamine with 280mg,orally

Primary Outcome Measures

Name	Time	Method
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	Pre-dose to 72 hours post-dose	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

Trial Locations

Locations (1)

TEDA International Cardiovascular Hospital; 🇨🇳 Tianjin, China