A Phase Ⅰa Study of Azilsartan Trimethylethanolamine in Healthy Volunteers

November 7, 2013 updated by: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China
        • Recruiting
        • TEDA International Cardiovascular Hospital
        • Contact:
          • Jie Hou, Associate Chief Physician
          • Phone Number: 86-022-65209939
        • Principal Investigator:
          • Jie Hou, Associate Chief Physician

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

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
Time Frame: Pre-dose to 72 hours post-dosee
Pre-dose to 72 hours post-dosee
Number of participants with adverse reactions
Time Frame: 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
Pre-dose to 72 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

October 31, 2013

First Submitted That Met QC Criteria

November 7, 2013

First Posted (Estimate)

November 15, 2013

Study Record Updates

Last Update Posted (Estimate)

November 15, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-AZTP1a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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