A Phase Ⅰa Study of Azilsartan Trimethylethanolamine in Healthy Volunteers

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01985152

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Health	Drug: Azilsartan Trimethylethanolamine Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TEDA International Cardiovascular Hospital	Tianjin		China

Sponsors and Collaborators

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Investigators

Principal Investigator: Jie Hou, Associate Chief Physician, TEDA International Cardiovascular Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiangsu Hansoh Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01985152

Other Study ID Numbers:

HS-AZTP1a

First Posted:

Nov 15, 2013

Last Update Posted:

Nov 15, 2013

Last Verified:

Nov 1, 2013

Additional relevant MeSH terms:

Choline

Azilsartan medoxomil

Study Results

No Results Posted as of Nov 15, 2013