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The purpose of this study is to evaluate the safety and tolerability of multiple doses escalation of Aolanti Weikang tablets to determine the MTD in healthy volunteers
This is a single-center, randomized, doule blind, placebo-controlled, multiple dose escalaction phase 1b study to evaluate the safety and tolerability of Aolanti Weikang tablets in healthy volunteers. Aolanti Weikang tablets is a Chinese patent drug designed to treat Functional dyspepsia (FD). The proposed dose escalaction levels is 3,6 and 8 tablets. If MTD is not established up to 8 tablets, the dose escalaction will be stopped. In each dose level, subjects will be randomly given orally Aolanti Weikang tablets or placebo tablets at a 3:1 ratio three times a day (tid) for 7 consecutive days, then will receive the Safety follow up for 14 days. No intrapatient dose-escalation is permitted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aolanti Weikang tablets | Experimental | 3,6 or 8 Aolanti Weikang tablets each time,tid |
|
| Placebo | Placebo Comparator | 3,6 or 8 tablets each time,tid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aolanti Weikang tablets | Drug | Aolanti Weikang tablets is a Chinese patent drug designed to treat Functional dyspepsia (FD). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum-tolerated Dose (MTD) of Aolanti Weikang tablets | Definition of MTD: the dose level at which 3 or more subjects experienced one or more dose limited toxicities | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number and grade of treatment-related adverse events (AEs) | All of the AE are assessed by NCI-CTCAE v4.03 | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xudong Tang | Xiyuan Hospital of China Academy of Chinese Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiyuan Hospital, China Academy of Chinese Medical Sciences | Beijing | Beijing Municipality | 100091 | China |
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| Placebo | Other | Placebo |
|