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...
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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 targets the corticotropin-releasing factor receptor, which is involved in the body's stress response. By modulating this receptor, the drug may influence emotional processing and potentially affect symptoms of depression and anxiety. This mechanism was studied in a Phase 1 trial measuring brain activation during emotional tasks.
GSK561679 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company conducted a Phase 1 clinical trial of the drug in the United States to evaluate its effects on brain activity in healthy female volunteers.
GSK561679 is in Phase 1 clinical development. A Phase 1 trial with the identifier NCT00513565 was completed, involving 22 healthy female volunteers in the United States. The drug is investigational and has not received FDA approval for any indication.
GSK561679 was studied in one completed Phase 1 clinical trial, NCT00513565, titled "A Study To Investigate Effects Of GSK561679 On Brain Activation During Emotional Processing In Healthy Volunteers." The trial enrolled 22 healthy female participants aged 18 years and older in the United States.
GSK561679 is a distinct investigational compound and is not known to be the same as any other marketed drug. It is being developed specifically for potential use in depressive and anxiety disorders, and its development is separate from other GSK products.