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This is a study to assess the food effect of TS-142 preliminary market formulation tablet in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fed condition | Experimental | Period in which subjects receive a single oral dose of TS-142 tablet in fed condition. |
|
| Fasted condition | Experimental | Period in which subjects receive a single oral dose of TS-142 tablet in fasted condition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-142 10 mg | Drug | Single-dose of 10 mg of TS-142 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration | Plasma concentration of unchanged form and its metabolite | Predose and up to 24 hours postdose |
| Pharmacokinetic parameters | Maximum plasma concentration of unchanged form and its metabolite (Cmax) | Predose and up to 24 hours postdose |
| Pharmacokinetic parameters | Time to maximum plasma concentration of unchanged form and its metabolite (tmax) | Predose and up to 24 hours postdose |
| Pharmacokinetic parameters | Area under the plasma concentration-time curve extrapolated to infinity of unchanged form and its metabolite (AUCinf) | Predose and up to 24 hours postdose |
| Pharmacokinetic parameters | Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of unchanged form and its metabolite (AUC0-last) | Predose and up to 24 hours postdose |
| Pharmacokinetic parameters | Terminal elimination rate constant of unchanged form and its metabolite (λz) | Predose and up to 24 hours postdose |
| Pharmacokinetic parameters | Elimination half-life of unchanged form and its metabolite (t1/2) | Predose and up to 24 hours postdose |
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Inclusion Criteria:
Other protocol defined inclusion criteria could apply.
Exclusion Criteria:
Other protocol defined exclusion criteria could apply.
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| Name | Affiliation | Role |
|---|---|---|
| Taisho Director | Taisho Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taisho Pharmaceutical Co., Ltd selected site | Tokyo | Japan |
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| ID | Term |
|---|---|
| C000723815 | TS-142 |
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| Pharmacokinetic parameters |
Apparent volume of distribution based on the terminal phase of unchanged form (Vz/F) |
| Predose and up to 24 hours postdose |
| Pharmacokinetic parameters | Apparent total body clearance of unchanged form (CL/F) | Predose and up to 24 hours postdose |