NCT01985152

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 15, 2013

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

November 15, 2013

Status Verified

November 1, 2013

Enrollment Period

3 months

First QC Date

October 31, 2013

Last Update Submit

November 7, 2013

Conditions

Health

Outcome Measures

Primary Outcomes (2)

  • 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

    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

Study Arms (8)

1.Azilsartan Trimethylethanolamine

EXPERIMENTAL

Single dose of Azilsartan Trimethylethanolamine with 8.75mg,orally

Drug: Azilsartan Trimethylethanolamine

2.Azilsartan Trimethylethanolamine

EXPERIMENTAL

Single dose of Azilsartan Trimethylethanolamine with 17.5mg,orally

Drug: Azilsartan Trimethylethanolamine

3.Azilsartan Trimethylethanolamine

EXPERIMENTAL

Single dose of Azilsartan Trimethylethanolamine with 35mg,orally

Drug: Azilsartan Trimethylethanolamine

4.Azilsartan Trimethylethanolamine

EXPERIMENTAL

Single dose of Azilsartan Trimethylethanolamine with 70mg,orally

Drug: Azilsartan Trimethylethanolamine

5.Azilsartan Trimethylethanolamine

EXPERIMENTAL

Single dose of Azilsartan Trimethylethanolamine with 140mg,orally

Drug: Azilsartan Trimethylethanolamine

6.Azilsartan Trimethylethanolamine

EXPERIMENTAL

Single dose of Azilsartan Trimethylethanolamine with 210mg,orally

Drug: Azilsartan Trimethylethanolamine

7.Azilsartan Trimethylethanolamine

EXPERIMENTAL

Single dose of Azilsartan Trimethylethanolamine with 280mg,orally

Drug: Azilsartan Trimethylethanolamine

Placebo

PLACEBO COMPARATOR

Placebo-matching tablets, orally

Drug: Placebo

Interventions

Azilsartan TrimethylethanolamineDRUG
1.Azilsartan Trimethylethanolamine2.Azilsartan Trimethylethanolamine3.Azilsartan Trimethylethanolamine4.Azilsartan Trimethylethanolamine5.Azilsartan Trimethylethanolamine6.Azilsartan Trimethylethanolamine7.Azilsartan Trimethylethanolamine
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males or females
  • Aged from 18 years to 45 years
  • Body mass index (BMI) 19 to 25kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TEDA International Cardiovascular Hospital

Tianjin, China

RECRUITING

Study Officials

  • Jie Hou, Associate Chief Physician

    TEDA International Cardiovascular Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Hou, Associate Chief Physician

CONTACT

86-022-65209939

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 15, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2013

Last Updated

November 15, 2013

Record last verified: 2013-11

Locations

CN(1)