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A Phase Ⅰa Study of Azilsartan Trimethylethanolamine in Healthy Volunteers

NCT ID: NCT01985152

Last Updated: 2013-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Brief Summary

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

Detailed Description

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Conditions

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Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1.Azilsartan Trimethylethanolamine

Single dose of Azilsartan Trimethylethanolamine with 8.75mg,orally

Group Type EXPERIMENTAL

Azilsartan Trimethylethanolamine

Intervention Type DRUG

2.Azilsartan Trimethylethanolamine

Single dose of Azilsartan Trimethylethanolamine with 17.5mg,orally

Group Type EXPERIMENTAL

Azilsartan Trimethylethanolamine

Intervention Type DRUG

3.Azilsartan Trimethylethanolamine

Single dose of Azilsartan Trimethylethanolamine with 35mg,orally

Group Type EXPERIMENTAL

Azilsartan Trimethylethanolamine

Intervention Type DRUG

4.Azilsartan Trimethylethanolamine

Single dose of Azilsartan Trimethylethanolamine with 70mg,orally

Group Type EXPERIMENTAL

Azilsartan Trimethylethanolamine

Intervention Type DRUG

5.Azilsartan Trimethylethanolamine

Single dose of Azilsartan Trimethylethanolamine with 140mg,orally

Group Type EXPERIMENTAL

Azilsartan Trimethylethanolamine

Intervention Type DRUG

6.Azilsartan Trimethylethanolamine

Single dose of Azilsartan Trimethylethanolamine with 210mg,orally

Group Type EXPERIMENTAL

Azilsartan Trimethylethanolamine

Intervention Type DRUG

7.Azilsartan Trimethylethanolamine

Single dose of Azilsartan Trimethylethanolamine with 280mg,orally

Group Type EXPERIMENTAL

Azilsartan Trimethylethanolamine

Intervention Type DRUG

Placebo

Placebo-matching tablets, orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Azilsartan Trimethylethanolamine

Intervention Type DRUG

Placebo

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jie Hou, Associate Chief Physician

Role: PRINCIPAL_INVESTIGATOR

TEDA International Cardiovascular Hospital

Locations

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TEDA International Cardiovascular Hospital

Tianjin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jie Hou, Associate Chief Physician

Role: CONTACT

Phone: 86-022-65209939

Facility Contacts

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Jie Hou, Associate Chief Physician

Role: primary

Other Identifiers

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HS-AZTP1a

Identifier Type: -

Identifier Source: org_study_id