Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Paxil manufactured by SmithKline Beecham Limited- Cidra- Puerto Rico · 1 trial · 1 indication
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC\_ss is the area under the curve during the steady-state period. The AUC\_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; h, hour; ml, milliliter; ng.h/ml, nanograms per hour per milliliter.
Cmin\_ss is defined as the minimum concentration of a drug observed after its administration, in steady-state. Cmin\_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses.
Cmax\_ss is defined as the maximum or "peak" concentration of a drug observed after its administration, in steady-state. Cmax\_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.
| Arm | Type | Description |
|---|---|---|
| Paxil CR Reference | ACTIVE_COMPARATOR | Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico, in Period 1, followed by Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada, in Period 2 |
| Paxil CR Test | ACTIVE_COMPARATOR | Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada, in Period 1, followed by Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico, in Period 2 |
| Name | Type | Description |
|---|---|---|
| Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico | DRUG | Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation) |
| Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada | DRUG | Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation) |
EXCLUSION CRITERIA: * hypersensitivity to the study drug or to compounds chemically related; * history of serious adverse events; * concurrent or recent use of other antidepressives, schizophrenia, anticonvulsant; * History of liver, heart, gastrointestinal or renal illness; * ECG findings not reco...
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