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This study is a single-dose, randomized, open-label, three-sequence, three-period crossover clinical trial to evaluate the effect of high-fat and low-fat meals on the pharmacokinetics of ammoxetine hydrochloride enteric-coated tablets in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting conditions | Experimental | Period in which subjects receive a single oral dose of ammoxetine hydrochloride enteric-coated tablets in fasting condition. |
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| High-fat fed conditions | Experimental | Period in which subjects receive a single oral dose of ammoxetine hydrochloride enteric-coated tablets in high-fat fed condition. |
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| Low-fat fed conditions | Experimental | Period in which subjects receive a single oral dose of ammoxetine hydrochloride enteric-coated tablets in low-fat fed condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ammoxetine hydrochloride enteric-coated tablets | Drug | Single-dose of 60 mg of ammoxetine hydrochloride enteric-coated tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| PK parameters | Maximum plasma concentration (Cmax) | up to 48 hours |
| PK parameters | Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf) | up to 48 hours |
| PK parameters | Area under the concentration-time curve from zero to the last measurable time (AUC0-t) | up to 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Hospital of Hebei Medical University, Hebei Tumor Hospital | Shijiazhuang | Hebei | 050035 | China |
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| Ammoxetine hydrochloride enteric-coated tablets | Drug | Single-dose of 60 mg of ammoxetine hydrochloride enteric-coated tablets |
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| Ammoxetine hydrochloride enteric-coated tablets | Drug | Single-dose of 60 mg of ammoxetine hydrochloride enteric-coated tablets |
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