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...
Top 20 of 31 competitors
Paxil is used for Depressive Disorder. It is a small molecule psychiatry medicine developed by GSK plc, which trades under the ticker GSK. The clinical program includes one completed Phase 1 trial conducted in Brazil with 60 enrolled participants.
Paxil is developed by GSK plc, which trades under the ticker GSK. Manufacturing is associated with SmithKline Beecham facilities in Cidra, Puerto Rico. The product is also referenced as Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited in Cidra, Puerto Rico.
Paxil is in Phase 1 development for Depressive Disorder. One Phase 1 trial has been completed and no trials are currently active. The completed study was randomized, active controlled, and enrolled 60 participants, including healthy volunteers, in Brazil.
Paxil has been studied in the Phase 1 trial NCT01339247, titled Paxil CR Bioequivalence Study Brazil - Fed Administration. That trial is completed, enrolled 60 participants aged 18 years and older of all sexes, and was conducted in Brazil in healthy volunteers with Depressive Disorder as the condition.