| Primary | AUC (Hour*ng/mL) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg | | Safety and evaluable pharmacokinetic populations = 24 randomized subjects. | Posted | | Mean | Standard Deviation | Hour*ng/mL | | Day 1 | | | | ID | Title | Description |
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| OG000 | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Brisdelle (paroxetine mesylate) Capsules 7.5 mg All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days. |
| | | Title | Denominators | Categories |
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| AUC0-last (Hour x ng/mL) | | | | AUC0-inf (Hour x ng/mL) | | | | AUC0-24 (Hour x ng/mL) | | |
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| Primary | Cmax (ng/mL) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg | | Safety and evaluable pharmacokinetic populations = 24 randomized subjects. | Posted | | Mean | Standard Deviation | ng/mL | | Day 1 | | | | ID | Title | Description |
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| OG000 | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Brisdelle (paroxetine mesylate) Capsules 7.5 mg All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days. |
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| Primary | Kel (Hour^-1) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg | | Safety and evaluable pharmacokinetic populations = 24 randomized subjects. | Posted | | Mean | Standard Deviation | Hour^(-1) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Brisdelle (paroxetine mesylate) Capsules 7.5 mg All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days. |
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| Primary | Mean t1/2 Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg | | Safety and evaluable pharmacokinetic populations = 24 randomized subjects. | Posted | | Mean | Standard Deviation | Hours | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Brisdelle (paroxetine mesylate) Capsules 7.5 mg All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days. |
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| Primary | Median t1/2 Single Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | | Safety and evaluable pharmacokinetic populations = 24 randomized subjects. | Posted | | Median | Full Range | hours | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Brisdelle (paroxetine mesylate) Capsules 7.5 mg All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days. |
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| Primary | AUC (Hour*ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | | Safety and evaluable pharmacokinetic populations = 24 randomized subjects. | Posted | | Mean | Standard Deviation | Hour*ng/mL | | Day 19 | | | | ID | Title | Description |
|---|
| OG000 | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Brisdelle (paroxetine mesylate) Capsules 7.5 mg All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days. |
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| Primary | Cmax (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | | Safety and evaluable pharmacokinetic populations = 24 randomized subjects. | Posted | | Mean | Standard Deviation | ng/mL | | Day 19 | | | | ID | Title | Description |
|---|
| OG000 | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Brisdelle (paroxetine mesylate) Capsules 7.5 mg All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days. |
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| Primary | Cmin (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | | Safety and evaluable pharmacokinetic populations = 24 randomized subjects. | Posted | | Mean | Standard Deviation | ng/mL | | Day 19 | | | | ID | Title | Description |
|---|
| OG000 | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Brisdelle (paroxetine mesylate) Capsules 7.5 mg All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days. |
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| Primary | Tmax (Hour) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | | Safety and evaluable pharmacokinetic populations = 24 randomized subjects. | Posted | | Mean | Full Range | Hours | | Day 19 | | | | ID | Title | Description |
|---|
| OG000 | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Brisdelle (paroxetine mesylate) Capsules 7.5 mg All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days. |
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| Primary | Accumulation Index Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg at Day 19 | Accumulation Index is the ratio of AUC 0-24 after multiple doses versus a single dose. It is the increase in drug plasma concentration after multiple dosing until a steady state is reached. In this case the steady state Accumulation Index was calculated at Day 19. Accumulation Index is calculated at the end of the dosing period. | Safety and evaluable pharmacokinetic populations = 24 randomized subjects. | Posted | | Mean | Full Range | Ratio | | Day 19 | | | | ID | Title | Description |
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| OG000 | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Brisdelle (paroxetine mesylate) Capsules 7.5 mg All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days. |
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| Primary | Fluctuation Index (%) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Fluctuation Index is (Cmax-Cmin)/Cavg,ss. It is peak trough fluctuation within one dosing interval at steady state. | Safety and evaluable pharmacokinetic populations = 24 randomized subjects. | Posted | | Mean | Full Range | Percentage of steady state concentration | | Day 19 | | | | ID | Title | Description |
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| OG000 | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Brisdelle (paroxetine mesylate) Capsules 7.5 mg All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days. |
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| Primary | Cavg,ss (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | | Safety and evaluable pharmacokinetic populations = 24 randomized subjects. | Posted | | Mean | Standard Deviation | ng/mL | | Day 19 | | | | ID | Title | Description |
|---|
| OG000 | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Brisdelle (paroxetine mesylate) Capsules 7.5 mg All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days. |
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| Primary | Ct (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | C(t) is the measured plasma level "Concentration" of the drug at "time = t" expressed as nanograms per milliliter. | Safety and evaluable pharmacokinetic populations = 24 randomized subjects. | Posted | | Mean | Standard Deviation | ng/mL | | Day 19 | | | | ID | Title | Description |
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| OG000 | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg | Brisdelle (paroxetine mesylate) Capsules 7.5 mg All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days. |
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