A Phase Ⅰa Study of Azilsartan Trimethylethanolamine in Healthy Volunteers

Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01985152
• Other study ID #: HS-AZTP1a
• Status: Recruiting
• Phase: Phase 1
• First received: October 31, 2013
• Last updated: November 7, 2013
• Start date: September 2013

Study information

• Verified date: November 2013
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: Jie Hou, Associate Chief Physician
• Phone: 86-022-65209939
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Health

Intervention

Drug:
• Azilsartan Trimethylethanolamine

• Placebo

Locations

Country	Name	City	State
China	TEDA International Cardiovascular Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study the Pharmacokinetics of Azilsartan Trimethylethanolamine by assessment of drug concentration through blood sample analysis		Pre-dose to 72 hours post-dosee	No
Primary	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	Yes