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The objective of this study is to evaluate the effect of food on the pharmacokinetics and safety after administration of ASP8825 in healthy non-elderly adult male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasted dosing preceding group | Experimental |
| |
| Fed dosing preceding group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP8825 | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) parameter of gabapentin: Cmax | Cmax: Maximum concentration | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing |
| PK parameters of gabapentin: AUClast | AUClast: Area under the concentration-time curve from the time of dosing extrapolated to the last measurable concentration | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing |
| Safety assessed by AEs | AEs: Adverse Events | Up to 8 days after the final study drug dosing |
| Safety assessed by Vital signs | Supine blood pressure, supine pulse rate and axillary body temperature | Up to 3 days after the each study drug dosing |
| Safety assessed by Laboratory tests | Hematology, blood biochemistry, and urinalysis | Up to 3 days after the each study drug dosing |
| Safety assessed by 12-lead ECGs | ECG: Electrocardiogram | Up to 3 days after the each study drug dosing |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of gabapentin tmax | tmax: Time of Cmax | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing |
| PK parameter of gabapentin: AUCinf | AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka | Japan |
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| ID | Term |
|---|---|
| C493250 | 1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid |
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| Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing |
| PK parameters of gabapentin: t1/2 | t1/2: Terminal elimination half-life | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing |
| PK parameters of gabapentin: CL/F | CL/F: Apparent total systemic clearance | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing |
| PK parameters of gabapentin: MRTinf | MRTinf: Mean residence time from the time of dosing extrapolated to time infinity | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing |
| PK parameters of gabapentin: MRTlast | MRTlast: Mean residence time from the time of dosing extrapolated to the last measurable concentration | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing |
| PK parameters of gabapentin: kel | kel: Terminal elimination rate constant | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hr after dosing |