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This is a randomized, double-blind, placebo-controlled, dose-escalation study in healthy Chinese subjects at single dose administration of Allisartan Isoproxil Tablets (240 mg ,480 mg or 720 mg)or placebo. The study design allows an assessment of 3 doses with safety monitoring and PK sampling to evaluate the safety, tolerability and PK profile of Allisartan Isoproxil Tablets.
This study will be conducted at 1 study center in Shenzhen. 18 healthy Chinese male and female participants per group, aged 18 to 65 inclusive, will be randomized in a 5:1 ratio to receive a single administration of Allisartan Isoproxil Tablets (240 mg ,480 mg or 720 mg)or placebo (54 participants in total). Each participant will participate in only 1 treatment group. Blood samples will be collected up to 72 hours post-dose for pharmacokinetic parameter calculation, and safety monitoring will continue until sample collection is complete.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allisartan Isoproxil Tablets 240mg | Active Comparator | Allisartan Isoproxil Tablets 240mg, QD |
|
| Allisartan Isoproxil Tablets 480mg | Active Comparator | Allisartan Isoproxil Tablets 480mg, QD |
|
| Allisartan Isoproxil Tablets 720mg | Active Comparator | Allisartan Isoproxil Tablets 720mg, QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allisartan Isoproxil Tablets 240mg or placebo | Drug | Allisartan Isoproxil Tablets 240mg or placebo, QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | Incidence of treatment-emergent adverse events during the whole study | up to Day 4 |
| Cmax | Observed maximum plasma concentration (Cmax) | Day 1 to Day 4 |
| AUC0-t | Plasma concentration-time curve from time zero extrapolated to the time of last quantifiable concentration (AUC0-t) | Day 1 to Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongying Yang, M.D. | Contact | 0755-22942636 | yanghy0119@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongying Yang, M.D. | Shenzhen People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen People's Hospital | Recruiting | Shenzhen | Guangdong | China |
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| Allisartan Isoproxil Tablets 480mg or placebo | Drug | Allisartan Isoproxil Tablets 480mg or placebo, QD |
|
| Allisartan Isoproxil Tablets 720mg or placebo | Drug | Allisartan Isoproxil Tablets 720mg or placebo, QD |
|
| ID | Term |
|---|---|
| C587132 | allisartan isoproxil |
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