Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Test formulation, Reference formulation · 2 trials · 2 indications
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 from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.
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 from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
Cmax is defined as the maximum or "peak" concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating bioavailability of drugs, by measuring the total amount of drug absorbed.
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 |
|---|---|---|
| tamsulosin Reference | ACTIVE_COMPARATOR | Reference drug administration followed by Test drug administration |
| tamsulosin Test | ACTIVE_COMPARATOR | Test drug administration followed by Reference drug administration |
| 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 | tamsulosin hydrochloride 0,4 mg (Synthon BV) |
| Reference formulation | DRUG | tamsulosin 0,4 mg (Boehringer Ingelheim) |
EXCLUSION CRITERIA: * Known hypersensitivity to the study drug (tamsulosin hydrochloride) or to compounds chemically related * History or presence of hepatic or gastrointestinal illnesses, or other condition that interferes over the drug's absorption, distribution, excretion or metabolism * History...
Top 20 of 29 competitors
GSK561679 is an investigational drug being studied for use in depressive disorder and anxiety disorders. It was evaluated in a Phase 1 clinical trial in healthy volunteers to investigate its effects on brain activation during emotional processing. The drug is still in clinical development and has not been approved by regulatory authorities.
GSK561679 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company conducted Phase 1 clinical trials to study the drug's effects in healthy volunteers and its potential use in psychiatric conditions such as depressive disorder and anxiety disorders.
GSK561679 is in Phase 1 clinical development. It has completed Phase 1 trials, including a study on brain activation during emotional processing in healthy volunteers. As an investigational drug, it is not yet approved and remains in early-stage clinical testing.
GSK561679 has been studied in Phase 1 clinical trials, including NCT00513565, which examined its effects on brain activation during emotional processing in healthy volunteers with depressive disorder and anxiety disorders. This trial was completed in the United States with 22 female participants.
GSK561679 is not the same as Paxil CR or Secotex. Paxil CR (paroxetine) and Secotex (tamsulosin) are separate drugs studied in bioequivalence trials listed alongside GSK561679 in the same developer's portfolio. GSK561679 is a distinct investigational compound with its own clinical development program.