HealthPhase 1NCT01985152
A Phase Ⅰa Study of Azilsartan Trimethylethanolamine in Healthy Volunteers
A Phase 1 study testing Azilsartan Trimethylethanolamine in people with Health, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the Pharmacokinetics and safety of Azilsartan Trimethylethanolamine in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Health
- What is being tested?
- Azilsartan Trimethylethanolamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or females
- Aged from 18 years to 45 years
- Body mass index (BMI) 19 to 25kg/m2
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Jie Hou, Associate Chief Physician contact
China1 site, 1 recruiting
- Recruiting
TEDA International Cardiovascular Hospital
Tianjin
Jie Hou, Associate Chief Physician, 86-022-65209939
Jie Hou, Associate Chief Physician
About this study
Official title: 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
- Conditions
- Health
- Being tested
- Azilsartan Trimethylethanolamine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azilsartan TrimethylethanolamineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1.Azilsartan Trimethylethanolamine | Experimental | Single dose of Azilsartan Trimethylethanolamine with 8.75mg,orally Receives: Drug: Azilsartan Trimethylethanolamine |
| 2.Azilsartan Trimethylethanolamine | Experimental | Single dose of Azilsartan Trimethylethanolamine with 17.5mg,orally Receives: Drug: Azilsartan Trimethylethanolamine |
| 3.Azilsartan Trimethylethanolamine | Experimental | Single dose of Azilsartan Trimethylethanolamine with 35mg,orally Receives: Drug: Azilsartan Trimethylethanolamine |
| 4.Azilsartan Trimethylethanolamine | Experimental | Single dose of Azilsartan Trimethylethanolamine with 70mg,orally Receives: Drug: Azilsartan Trimethylethanolamine |
| 5.Azilsartan Trimethylethanolamine | Experimental | Single dose of Azilsartan Trimethylethanolamine with 140mg,orally Receives: Drug: Azilsartan Trimethylethanolamine |
| 6.Azilsartan Trimethylethanolamine | Experimental | Single dose of Azilsartan Trimethylethanolamine with 210mg,orally Receives: Drug: Azilsartan Trimethylethanolamine |
| 7.Azilsartan Trimethylethanolamine | Experimental | Single dose of Azilsartan Trimethylethanolamine with 280mg,orally Receives: Drug: Azilsartan Trimethylethanolamine |
| Placebo | Placebo comparator | Placebo-matching tablets, orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the Pharmacokinetics of Azilsartan Trimethylethanolamine by assessment of drug concentration through blood sample analysis
Measured: 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
Measured: Pre-dose to 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jie Hou, Associate Chief Physician, Principal investigator, TEDA International Cardiovascular Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985152
- Sponsor's protocol ID
- HS-AZTP1a
- Status last verified
- Nov 2013
- First submitted
- 31 Oct 2013
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Phase I, Single-center Evaluation of the Single-dose Pharmacokinetics Study of Azilsartan Trimethylethanolamine
- ClinicalTrials.gov ID
- NCT01985152
- Acronym / sponsor ID
- HS-AZTP1a
- Conditions
- Health
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (estimated)
- First posted
- 15 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the Pharmacokinetics and safety of Azilsartan Trimethylethanolamine in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1.Azilsartan Trimethylethanolamine | Experimental | Drug: Azilsartan TrimethylethanolamineSingle dose of Azilsartan Trimethylethanolamine with 8.75mg,orally |
| 2.Azilsartan Trimethylethanolamine | Experimental | Drug: Azilsartan TrimethylethanolamineSingle dose of Azilsartan Trimethylethanolamine with 17.5mg,orally |
| 3.Azilsartan Trimethylethanolamine | Experimental | Drug: Azilsartan TrimethylethanolamineSingle dose of Azilsartan Trimethylethanolamine with 35mg,orally |
| 4.Azilsartan Trimethylethanolamine | Experimental | Drug: Azilsartan TrimethylethanolamineSingle dose of Azilsartan Trimethylethanolamine with 70mg,orally |
| 5.Azilsartan Trimethylethanolamine | Experimental | Drug: Azilsartan TrimethylethanolamineSingle dose of Azilsartan Trimethylethanolamine with 140mg,orally |
| 6.Azilsartan Trimethylethanolamine | Experimental | Drug: Azilsartan TrimethylethanolamineSingle dose of Azilsartan Trimethylethanolamine with 210mg,orally |
| 7.Azilsartan Trimethylethanolamine | Experimental | Drug: Azilsartan TrimethylethanolamineSingle dose of Azilsartan Trimethylethanolamine with 280mg,orally |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo-matching tablets, orally |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males or females
- Aged from 18 years to 45 years
- Body mass index (BMI) 19 to 25kg/m2
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azilsartan Trimethylethanolamine | Drug | 1.Azilsartan Trimethylethanolamine, 2.Azilsartan Trimethylethanolamine, 3.Azilsartan Trimethylethanolamine, 4.Azilsartan Trimethylethanolamine, 5.Azilsartan Trimethylethanolamine, 6.Azilsartan Trimethylethanolamine, 7.Azilsartan Trimethylethanolamine |
| Placebo | Drug | Placebo |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
Related trials for Health
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Hou, Associate Chief Physician contact
Jie Hou, Associate Chief Physician principal investigator
TEDA International Cardiovascular Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azilsartan Trimethylethanolamine in people with Health, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Hou, Associate Chief Physician (86-022-65209939), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2013.