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Also known as Paroxetine IR tablets A
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...