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| Name | Class |
|---|---|
| Academy Military Medical Science, China | INDUSTRY |
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The purpose of this study is to determine the safety and tolerability, and to evaluate the pharmacokinetic characteristics and food effect of Methosulide after oral administration in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methosulide | Experimental | Methosulide, oral administration |
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| Placebo | Placebo Comparator | Placebo, oral administration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methosulide | Drug | Tolerability Study: Period I:Single oral administration,dose-escalation of Methosulide(six dose groups:25mg-250mg) Period II:Repeated oral administration of Methosulide(group 1:MTD（maximum tolerated dose）/250mg ,group 2:depending on the adverse drug reaction,150mg/250mg) Pharmacokinetic Study: Period I:Single oral administration,dose-escalation of Methosulide(three dose groups:50mg,100mg,200mg/250mg) Period II:Repeated oral administration of Methosulide(group 1:MTD（maximum tolerated dose）/250mg ,group 2:depending on the adverse drug reaction,150mg/250mg) Food Effect on the Pharmacokinetics: single dose(100mg),two status(Feeding and fasting), washout period(7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single and repeated oral administration of Methosulide as measured by the frequency of drug-related clinical adverse events in healthy adults. | Adverse events, vital signs, electrocardiograms, physical exams, and clinical laboratory assessments will be assessed prior to, during, and after treatment | Period I: single dose,Baseline - 7 Days;Period II: repeated dose,Baseline - 14 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of single oral administration of Methosulide and effect of food in healthy adults. | Baseline - 7 Days | |
| Tmax of single oral administration of Methosulide and effect of food in healthy adults. | Baseline - 7 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ZHENG Heng | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan，Hubei | China |
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| Placebo | Drug | Placebo to match with experimental groups |
|
| area under curve(AUC) of single oral administration of Methosulide and effect of food in healthy adults. | Baseline - 7 Days |
| t1/2α of single oral administration of Methosulide and effect of food in healthy adults. | Baseline - 7 Days |
| t1/2β of single oral administration of Methosulide and effect of food in healthy adults. | Baseline - 7 Days |
| Vd of single oral administration of Methosulide and effect of food in healthy adults. | Baseline - 7 Days |
| Cls of single oral administration of Methosulide and effect of food in healthy adults. | Baseline - 7 Days |
| Css of repeated oral administration of Methosulide in healthy adults. | Baseline - 14 Days |
| Cmax of repeated oral administration of Methosulide in healthy adults. | Baseline - 14 Days |
| Tmax of repeated oral administration of Methosulide in healthy adults. | Baseline - 14 Days |
| area under curve(AUC) of repeated oral administration of Methosulide in healthy adults. | Baseline - 14 Days |
| t1/2α of repeated oral administration of Methosulide in healthy adults. | Baseline - 14 Days |
| t1/2β of repeated oral administration of Methosulide in healthy adults. | Baseline - 14 Days |
| Vd of repeated oral administration of Methosulide in healthy adults. | Baseline - 14 Days |
| Cls of repeated oral administration of Methosulide in healthy adults. | Baseline - 14 Days |