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).

BE analysis Population. BE analysis Population comprised of all randomized participants who completed all the planned treatments and provided at least one evaluable primary PK parameter data from both period 1 and period 2. Only those participants with data available at the specified data points were analyzed.

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).

BE analysis Population. Only those participants with data available at the specified data points were analyzed.

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).

BE analysis Population

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).

BE analysis Population

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.

BE analysis Population

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.

BE analysis Population.

Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Median and full range of Tmax have been presented.

Pharmacokinetic Population. PK Population comprised of all randomized participants received at least one dose of study treatment and provided at least one evaluable PK concentration data. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Median and full range of Tmax have been presented.

Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI of Lambda z have been presented.

Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI of Lambda z have been presented.

Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI have been presented.

Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI have been presented.

Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function. Data has been presented treatment-wise.

Safety Population. Safety Population comprised of all randomized participants who received at least one dose of study treatment. Only those participants with data available at the specified data points were analyzed.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function. Data has been presented treatment-wise.

Safety Population

Blood samples were collected to analyze the clinical chemistry laboratory parameters; alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST),calcium,creatinine, glucose, potassium (Pot) and sodium. PCI ranges were ALT (high: >=2 times upper limit of normal [ULN] units per liter [U/L]),albumin (low: <30 grams per liter),ALP (low: <20 international units per liter [IU/L] and high: >200 IU/L), AST (high: >=2 times ULN U/L),calcium (low: <2 millimoles per liter [mmol/L] and high: >2.75 mmol/L),creatinine (high: >133 micromoles per liter), glucose (low: <3 mmol/L and high: >9 mmol/L), Pot (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.

Safety Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected to analyze the clinical chemistry laboratory parameters; ALT, albumin, ALP, AST, calcium, creatinine, glucose, Pot and sodium. PCI ranges were ALT (high: >=2 times ULN U/L), albumin (low: <30 grams per liter), ALP (low: <20 IU/L and high: >200 IU/L), AST (high: >=2 times ULN U/L), calcium (low: <2 mmol/L and high: >2.75 mmol/L), creatinine (high: >133 micromoles per liter), glucose (low: <3 mmol/L and high: >9 mmol/L), Pot (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.

Safety Population

Blood samples were collected to analyze; hematocrit(Hct),hemoglobin(Hb),erythrocytes and platelets. PCI ranges; Hct(Male[low: <0.03 proportion of red blood cells in blood and high: >0.54 proportion of red blood cells in blood] and Female[low: <0.04 proportion of red blood cells in blood and high: >0.54 proportion of red blood cells in blood]),Hb(Male [low: <110 grams per liter and high: >180 grams per liter) and Female[low: <100 grams per liter and high: >170 grams per liter]),erythrocytes(Male [low: <4.5x10^12 cells per liter and high: >5.5x10^12 cells per liter] and Female[low: <4 x10^12 cells per liter and high: >5 x10^12 cells per liter]) and platelets(low: <80x10^9 cells per liter and high: >400x10^9 cells per liter). Participants were counted in the category that their value changed to(low, normal or high). If values were unchanged(example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category.Data has been presented treatment-wise.](streamdown:incomplete-link)

Safety Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected to analyze; Hct, Hb, erythrocytes and platelets. PCI ranges were Hct (Male [low: <0.03 proportion of red blood cells in blood and high: >0.54 proportion of red blood cells in blood] and Female [low: <0.04 proportion of red blood cells in blood and high: >0.54 proportion of red blood cells in blood]), Hb (Male [low: <110 grams per liter and high: >180 grams per liter) and Female [low: <100 grams per liter and high: >170 grams per liter]), erythrocytes (Male [low: <4.5x10^12 cells per liter and high: >5.5x10^12 cells per liter] and Female [low: <4 x10^12 cells per liter and high: >5 x10^12 cells per liter]) and platelets (low: <80x10^9 cells per liter and high: >400x10^9 cells per liter). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.](streamdown:incomplete-link)

Safety Population

Urine samples were collected to assess urine occult blood, urine glucose, urine ketones, urine protein and monitor urine potential of hydrogen (pH). The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters (except urine pH) were recorded as negative and positive, indicating proportional concentrations in the urine sample. pH is a measure of hydrogen ion concentration and is used to determine the acidity or alkalinity of urine. Urine pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 6.5, 7 or 8. Data has been presented treatment-wise.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Urine samples were collected to assess urine occult blood, urine glucose, urine ketones, urine protein and monitor urine pH. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters (except urine pH) were recorded as negative and positive, indicating proportional concentrations in the urine sample. pH is a measure of hydrogen ion concentration and is used to determine the acidity or alkalinity of urine. Urine pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 6.5, 7 or 8. Data has been presented treatment-wise.

Safety Population

A single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QT corrected (QTc) intervals. Clinically significant abnormal ranges were: heart rate: lower:<50 beats per minute and upper: >110 beats per minute; QT: Upper: >400 milliseconds (msec); QTc: Upper: >450 msec; PR: lower: <110 msec and upper: >220 msec; QRS: lower: <60 msec and upper: >120 msec. The number of participants with abnormal findings for ECG parameters have been presented. Data has been presented treatment-wise.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

A single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTc intervals. Clinically significant abnormal ranges were: heart rate: lower :<50 beats per minute and upper: >110 beats per minute; QT: Upper: >400 msec; QTc: Upper: >450 msec; PR: lower: <110 msec and upper: >220 msec; QRS: lower: <60 msec and upper: >120 msec. The number of participants with abnormal findings for ECG parameters have been presented. Data has been presented treatment-wise.

Safety Population

Vital signs including DBP and SBP were measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Vital signs including DBP and SBP were measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.

Safety Population

Vital sign including PR was measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Vital sign including PR was measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.

Safety Population

Vital sign including RR was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.

Safety Population. Only those participants with data available at the specified data points were analyzed.

Vital sign including RR was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.

Safety Population

Vital sign including temperature was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.

Safety Population. Only those participants with data available at the specified data points were analyzed.

Vital sign including temperature was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.

Safety Population