Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chinese Academy of Sciences | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the safety and tolerability, and to evaluate the pharmacokinetic characteristics of Mianhuahua Flavonoids Tablets after oral administration in healthy adult subjects.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mianhuahua Flavonoids Tablets | Experimental | Mianhuahua Flavonoids Tablets, oral administration |
|
| Placebo | Placebo Comparator | Placebo, oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mianhuahua Flavonoids Tablets | Drug | Tolerability Study: Period I:Single oral administration,dose-escalation of Mianhuahua Flavonoids Tablets(seven dose groups:0.3g-5.4g) Period II:Repeated oral administration of Mianhuahua Flavonoids Tablets (group 1:MTD(maximum tolerated dose)/1.5g, TID, group 2:depending on the adverse drug reaction,1.8g/1.2g, TID) Pharmacokinetic Study: Period I:Single oral administration,dose-escalation of Mianhuahua Flavonoids Tablets(six dose groups: 0.9g, 1.8g, 2.7g, 3.6g, 4.5g, 5.4g) Period II:Repeated oral administration of Mianhuahua Flavonoids Tablets (group 1:MTD(maximum tolerated dose)/1.5g, TID, group 2:depending on the adverse drug reaction,1.8g/1.2g, TID) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single and repeated oral administration of Mianhuahua Flavonoids Tablets as measured by the frequency of drug-related clinical adverse events in healthy adults. | Safety and tolerability will be evaluated through Composite Metrics:adverse events, vital signs, electrocardiograms, physical exams, and clinical laboratory assessments. | Period I: single dose,up to 7 Days;Period II: repeated dose,up to 36 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults. | up to 24h | |
| Tmax of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults. | up to 24h |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MU Dan dan | Contact | 86-0991-3768609 | mudandan@renfu.com.cn | |
| YIN Hai long | Contact | 86-0991-3768609 | yinhailong@renfu.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| QIU Fu rong | Shuguang Hospital affiliated with Shanghai University of TCM | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Placebo to match with experimental groups |
|
| area under curve(AUC) of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults. | up to 24h |
| t1/2 of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults. | up to 24h |
| Vd of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults. | up to 24h |
| Cls of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults. | up to 24h |
| Css_max of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults. | up to 29 days |
| Css_min of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults. | up to 29 days |
| Tss_max of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults. | up to 29 days |
| area under curve of steady state(AUCss) of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults. | up to 29 days |
| Degree of fluctuation(DF) of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults. | up to 29 days |