A Phase Ⅰa Study of Azilsartan Trimethylethanolamine in Healthy Volunteers

Hansoh Pharma

Status and phase: Unknown; Phase 1

Conditions: Health

Treatments: Drug: Azilsartan Trimethylethanolamine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01985152

HS-AZTP1a

Details and patient eligibility

About

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

Enrollment: 62 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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62 participants in 8 patient groups, including a placebo group

1.Azilsartan Trimethylethanolamine

Experimental group

Description:

Single dose of Azilsartan Trimethylethanolamine with 8.75mg,orally

Treatment:

Drug: Azilsartan Trimethylethanolamine

2.Azilsartan Trimethylethanolamine

Experimental group

Description:

Single dose of Azilsartan Trimethylethanolamine with 17.5mg,orally

Treatment:

Drug: Azilsartan Trimethylethanolamine

3.Azilsartan Trimethylethanolamine

Experimental group

Description:

Single dose of Azilsartan Trimethylethanolamine with 35mg,orally

Treatment:

Drug: Azilsartan Trimethylethanolamine

4.Azilsartan Trimethylethanolamine

Experimental group

Description:

Single dose of Azilsartan Trimethylethanolamine with 70mg,orally

Treatment:

Drug: Azilsartan Trimethylethanolamine

5.Azilsartan Trimethylethanolamine

Experimental group

Description:

Single dose of Azilsartan Trimethylethanolamine with 140mg,orally

Treatment:

Drug: Azilsartan Trimethylethanolamine

6.Azilsartan Trimethylethanolamine

Experimental group

Description:

Single dose of Azilsartan Trimethylethanolamine with 210mg,orally

Treatment:

Drug: Azilsartan Trimethylethanolamine

7.Azilsartan Trimethylethanolamine

Experimental group

Description:

Single dose of Azilsartan Trimethylethanolamine with 280mg,orally

Treatment:

Drug: Azilsartan Trimethylethanolamine

Placebo

Placebo Comparator group

Description:

Placebo-matching tablets, orally

Treatment:

Drug: Placebo