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| Name | Class |
|---|---|
| Shanghai Pharmaceuticals Holding Co., Ltd | INDUSTRY |
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The goal of this clinical trial is to evaluate the pharmacokinetic (PK) characteristics of single oral doses of SPH3348 tablets in healthy subjects under fasting and fed conditions, as well as the impact of food on PK.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single oral administration of SPH3348 tablets under fasting condition | Active Comparator | Single oral administration of SPH3348 tablets(480 mg) under fasting condition |
|
| Single oral administration of SPH3348 tablets under fed condition | Active Comparator | Single oral administration of SPH3348 tablets(480 mg) under fed condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPH3348 | Drug | Single oral administration of SPH3348 tablets(480mg) under fasting and fed conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Peak Concentration | Cmax occurs within 1.5 to 4 hours after dosing |
| Tmax | "Time to Reach Maximum Concentration | From administration to reaching maximum plasma concentration, typically around 3 hours |
| AUC0-t | AUC0-t is measured from time 0 to 32 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | through study completion, an average of 17 days |
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Inclusion Criteria:
To be eligible for this trial, participants must meet all the following inclusion criteria:
Exclusion Criteria:
Participants who meet any of the following exclusion criteria will be excluded:
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| Name | Affiliation | Role |
|---|---|---|
| yu | National Drug Clinical Trial Institution of West China Second Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Second University Hospital | Chengdu | China |
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Randomized, Open-label, Single-dose, Two-period, Two-sequence Crossover Design
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