Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01316926 | Paxil CR Bioequivalence Study Brazil | PHASE1 | COMPLETED | 60 | — | — | Sep 9, 2009 | Oct 5, 2009 | Jun 20, 2018 | 1 | Brazil |
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\_steady-state (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, nanogram; h, hour; ml, milliliter. ng.h/ml, nanograms per hour per milliliter.
Cmin\_steady-state (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\_steady-state (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 | Reference drug administration followed by test drug administration |
| Paxil CR Test | ACTIVE_COMPARATOR | Test drug administration followed by Reference drug administration |
| Name | Type | Description |
|---|---|---|
| Test formulation | DRUG | Paroxetine Hydrochloride 25 miligrams (mg) tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation) |
| Reference formulation | DRUG | Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference 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...