Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Paroxetine IR A · 1 trial · 1 indication
Blood samples were collected at designated time points. Pharmacokinetic (PK) parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of bioequivalence (BE). Point estimate and associated adjusted 90% confidence interval (CI) of difference between both the treatments were provided for AUC(0-infinity).
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-infinity).
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-t).
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-t).
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for Cmax.
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for Cmax.
| Arm | Type | Description |
|---|---|---|
| AB treatment sequence receivers in fasting group | EXPERIMENTAL | Eligible subjects will receive a single dose of Paroxetine IR tablets A in Period 1 followed by Paroxetine IR tablets B in Period 2 in fasting state. |
| BA treatment sequence receivers in fasting group | EXPERIMENTAL | Eligible subjects will receive a single dose of Paroxetine IR tablets B in Period 1 followed by Paroxetine IR tablets A in Period 2 in fasting state. |
| AB treatment sequence receivers in fed group | EXPERIMENTAL | Eligible subjects will receive a single dose of Paroxetine IR tablets A in Period 1 followed by Paroxetine IR tablets B in Period 2 in fed state. |
| BA treatment sequence receivers in fed group | EXPERIMENTAL | Eligible subjects will receive a single dose of Paroxetine IR tablets B in Period 1 followed by Paroxetine IR tablets A in Period 2 in fed state. |
| Name | Type | Description |
|---|---|---|
| Paroxetine IR tablets A | DRUG | Paroxetine IR tablets A will be the investigational drug. These are film coated tablets with unit dose strength of 20 milligrams (mg) and will be administered via oral route. These tablets will be manufactured in GSKT. |
| Paroxetine IR tablets B | DRUG | Paroxetine IR tablets B will be the reference drug. These are film coated tablets with unit dose strength of 20 mg and will be administered via oral route. These tablets will be manufactured in Mississauga. |
Inclusion Criteria: * Able to actively communicate with the investigator and to complete the study-related documents; able to understand the contents of the Informed consent form (ICF) and to sign a written ICF prior to any study-specific procedures. * Males and females aged between 18 and 45 years...
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Paroxetine IR A is an immediate-release tablet formulation of paroxetine developed by GSK plc for anxiety disorders. It is a small molecule drug and is also known as Paroxetine IR tablets A. The formulation has been studied in a Phase 1 bioequivalence trial in healthy Chinese subjects.
Paroxetine IR A is being developed for anxiety disorders. The only listed clinical trial enrolled healthy adult volunteers rather than patients, and it was designed as a bioequivalence study comparing tablets manufactured at two GSK sites. No efficacy in patients has been established for this specific formulation.
Paroxetine IR A targets SLC6A4, the serotonin transporter. It is classified as an inhibitor of this target. By inhibiting SLC6A4, the drug acts on serotonin reuptake, which is the mechanism associated with its use in anxiety disorders.
Paroxetine IR A is developed by GSK plc, which trades under the ticker GSK. The bioequivalence trial compared immediate-release tablets manufactured at GlaxoSmithKline Tianjin (GSKT) and a Mississauga site, indicating both manufacturing locations are involved in the product.
Paroxetine IR A is in Phase 1 development. Its single listed trial, NCT03329573, is a completed Phase 1 bioequivalence study. The drug is investigational, and the available information does not indicate that this formulation has received FDA approval.
Paroxetine IR A has been studied in one clinical trial, NCT03329573, titled a bioequivalence study of paroxetine immediate-release tablets manufactured in GlaxoSmithKline Tianjin (GSKT) and Mississauga sites in healthy Chinese subjects. The Phase 1 trial was completed, enrolled 85 participants, was randomized and controlled, and took place in China.
Yes, Paroxetine IR A is also known as Paroxetine IR tablets A. Both names refer to the same immediate-release paroxetine tablet formulation developed by GSK plc for anxiety disorders, studied in the Phase 1 bioequivalence trial NCT03329573.