Bioequivalence Study of Paroxetine Immediate Release (IR) Tablets Manufactured in GlaxoSmithKline Tianjin (GSKT) and Mississauga Sites in Healthy Chinese Subjects

Randomized, Open Label, 2-way Crossover, Single Dose Bioequivalence Study of Paroxetine IR Tablets Manufactured in GSKT and Mississauga Sites in Healthy Chinese Participants Under Fasting and Fed Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03329573

Enrollment

Registered

2017-11-06

Start date

2018-05-30

Completion date

2018-08-03

Last updated

2020-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders

Keywords

Cross-over, Chinese, GSKT, Mississauga, Healthy, Bioequivalence, Paroxetine

Brief summary

Paroxetine is a selective serotonin reuptake inhibitor (SSRI) and paroxetine IR tablets have been approved for the treatment of three anxiety indications in China. This bioequivalence study will evaluate Paroxetine IR tablets manufactured in GSKT (A) and Mississauga (B) sites in healthy Chinese subjects under fasting and fed conditions to support the quality consistency evaluation. This is a single dose, open-label, randomized, two-period crossover study and will include a screening period (up to 7 days), two open-label treatment periods (up to 16 days) and a follow-up phase (up to 14 days after last-dose). The whole study will be divided into two groups, one for fasting condition enrolling approximately 36 subjects and another for fed condition for which approximately 44 subjects will be enrolled. In both groups, eligible subjects will be randomized to receive single dose of Paroxetine IR tablets A or B in a cross-over manner.

Interventions

DRUGParoxetine IR tablets A

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.

DRUGParoxetine IR tablets B

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Masking description

This study is an open-label treatment period; hence, masking will not be performed.

Intervention model description

In this study, each subject will receive paroxetine IR 40mg A or B in a cross-over manner

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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 inclusive, at the time of signing the informed consent. * Non-smoking healthy males and females as assessed by medical history and physical examination. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters which are not specifically listed in the inclusion or

Exclusion criteria

, outside the reference range for the population being studied may be included only if the Investigator (in consultation with the GSK Medical Monitor if necessary) agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * Body weight\>=50 kilograms (kg) (male) or 45kg(female) and Body mass index (BMI) 19.0 to 26.0 kg per meter square (kg/m\^2) (inclusive). * A female subject is eligible to participate if she is of: Child-bearing potential with negative pregnancy test as determined by serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing and agrees to use the one of the defined contraception method during the study and until follow up contact. * Male Subjects with female partners of child-bearing potential must agree to use one of the defined contraception methods during the study and until follow up contact. * ALT, ALP and total bilirubin \<=1.5x upper limit of normal (ULN) (isolated bilirubin \>1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent). * Based on single or averaged corrected QT interval (QTc) values of triplicate ECGs obtained over a brief recording period: QTc \< 450 milliseconds (msec); or QTc \< 480 msec in subjects with bundlebranch block.

Design outcomes

Primary

Measure	Time frame	Description
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period	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).
AUC(0-infinity) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period	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).
Area Under the Concentration-time Curve From Administration Extrapolated to the Last Time of Quantifiable Concentration (AUC[0-t]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period	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).
AUC(0-t) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period	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).
Maximum Observed Concentration (Cmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period	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.
Cmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period	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.

Secondary

Measure	Time frame	Description
Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Under Fed Condition	Up to Day 26	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.
Number of Participants With Non-SAE and SAEs Under Fasting Condition	Up to Day 26	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.
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Day 16	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.
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Day 16	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.
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Day 16	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.
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Day 16	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.
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Baseline (Day-7 to Day -1) and Day 16	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.
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Baseline (Day-7 to Day -1) and Day 16	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.
Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters Under Fed Condition	Baseline (Day-7 to Day -1) and Day 16	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.
Time to Reach Maximum Observed Concentration (Tmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period	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.
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16	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.
DBP and SBP at Indicated Time-points Under Fasting Condition	Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16	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.
Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16	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.
Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16	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.
Respiratory Rate (RR) at Indicated Time-point Under Fed Condition	Day 11	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.
RR at Indicated Time-point Under Fasting Condition	Day 11	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.
Temperature at Indicated Time-point Under Fed Condition	Day 11	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.
Temperature at Indicated Time-point Under Fasting Condition	Day 11	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.
Number of Participants With Clinically Significant Abnormal Findings for ECG Parameters Under Fasting Condition	Baseline (Day-7 to Day -1) and Day 16	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.
Tmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period	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.
Terminal Elimination Rate Constant (Lambda z) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period	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.
Lambda z of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period	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.
Terminal Elimination Half-life (t1/2) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period	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.
t1/2 of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition	Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period	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.

Countries

China

Participant flow

Recruitment details

This was a single dose, open-label, randomized, two-period crossover study to demonstrate the bioequivalence of Paroxetine immediate release (IR) tablets manufactured in GlaxoSmithKline Tianjin (GSKT) (A) and Mississauga (B) sites in healthy Chinese participants under fasting and fed conditions.

Pre-assignment details

Participants received treatment in one of the two sequences; treatment A (GSKT, Paroxetine IR investigational drug) followed by treatment B (Mississauga, Paroxetine IR reference drug) or vice versa in each of the treatment period 1 and 2. A total of 85 (47 under fed condition and 38 under fasting condition) participants were enrolled.

Participants by arm

Arm	Count
Paroxetine 40 mg, GSKT Followed by Mississauga- Fed Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 milligrams (mg) (20 mg\2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fed condition.	23
Paroxetine 40 mg, Mississauga Followed by GSKT- Fed Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment A: GSKT, Paroxetine IR 40 mg (20 mg\2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fed condition.	24
Paroxetine 40 mg, GSKT Followed by Mississauga- Fasted Eligible participants received a single dose of treatment A: GSKT, Paroxetine IR 40 milligrams (mg) (20 mg\2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fasting condition.	19
Paroxetine 40 mg, Mississauga Followed by GSKT- Fasted Eligible participants received a single dose of treatment B: Mississauga, Paroxetine IR 40 mg (20 mg\2 tablets) administered orally on Day 1 in treatment period 1. It was followed by a washout period from Day 6 to Day 11. Participants received treatment A: GSKT, Paroxetine IR 40 mg (20 mg\2 tablets) administered orally on Day 12 in treatment period 2. All these doses were administered under fasting condition.	19
Total	85

Withdrawals & dropouts

Period	Reason	FG000	FG001
Treatment Period 1 (Up to 5 Days)	Adverse Event	0	1
Treatment Period 1 (Up to 5 Days)	Withdrawal by Subject	1	2
Treatment Period 2 (Day 12 to Day 26)	Adverse Event	0	1
Treatment Period 2 (Day 12 to Day 26)	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Paroxetine 40 mg, GSKT Followed by Mississauga- Fed	Paroxetine 40 mg, Mississauga Followed by GSKT- Fed	Paroxetine 40 mg, GSKT Followed by Mississauga- Fasted	Paroxetine 40 mg, Mississauga Followed by GSKT- Fasted	Total
Age, Continuous	30.3 Years STANDARD_DEVIATION 7.53	27.1 Years STANDARD_DEVIATION 5.63	25.4 Years STANDARD_DEVIATION 5.86	28.1 Years STANDARD_DEVIATION 6.17	27.3 Years STANDARD_DEVIATION 6.46
Race/Ethnicity, Customized Race Asian - East Asian Heritage	23 Participants	24 Participants	19 Participants	19 Participants	85 Participants
Sex: Female, Male Female	11 Participants	10 Participants	9 Participants	10 Participants	40 Participants
Sex: Female, Male Male	12 Participants	14 Participants	10 Participants	9 Participants	45 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 44	0 / 46	0 / 38	0 / 38
other Total, other adverse events	14 / 44	13 / 46	12 / 38	16 / 38
serious Total, serious adverse events	0 / 44	0 / 46	0 / 38	0 / 38

Outcome results

Primary

Area Under the Concentration-time Curve From Administration Extrapolated to the Last Time of Quantifiable Concentration (AUC[0-t]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition

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).

Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period

Population: BE analysis Population

Arm	Measure	Value (GEOMETRIC_MEAN)
Paroxetine 40 mg, GSKT- Fed	Area Under the Concentration-time Curve From Administration Extrapolated to the Last Time of Quantifiable Concentration (AUC[0-t]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition	866.85 Hour*nanogram per milliliter
Paroxetine 40 mg, Mississauga- Fed	Area Under the Concentration-time Curve From Administration Extrapolated to the Last Time of Quantifiable Concentration (AUC[0-t]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition	814.75 Hour*nanogram per milliliter

90% CI: [1.01, 1.12]

Primary

Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition

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).

Population: 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.

Arm	Measure	Value (GEOMETRIC_MEAN)
Paroxetine 40 mg, GSKT- Fed	Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition	860.54 Hour*nanogram per milliliter
Paroxetine 40 mg, Mississauga- Fed	Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition	812.49 Hour*nanogram per milliliter

90% CI: [1.006, 1.115]

Primary

AUC(0-infinity) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition

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

Arm	Measure	Value (GEOMETRIC_MEAN)
Paroxetine 40 mg, GSKT- Fed	AUC(0-infinity) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition	742.07 Hour*nanogram per milliliter
Paroxetine 40 mg, Mississauga- Fed	AUC(0-infinity) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition	745.22 Hour*nanogram per milliliter

90% CI: [0.947, 1.047]

Primary

AUC(0-t) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition

Population: BE analysis Population

Arm	Measure	Value (GEOMETRIC_MEAN)
Paroxetine 40 mg, GSKT- Fed	AUC(0-t) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition	750.49 Hour*nanogram per milliliter
Paroxetine 40 mg, Mississauga- Fed	AUC(0-t) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition	753.83 Hour*nanogram per milliliter

90% CI: [0.949, 1.044]

Primary

Cmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition

Population: BE analysis Population.

Arm	Measure	Value (GEOMETRIC_MEAN)
Paroxetine 40 mg, GSKT- Fed	Cmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition	36.86 Nanogram per milliliter
Paroxetine 40 mg, Mississauga- Fed	Cmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition	36.15 Nanogram per milliliter

90% CI: [0.968, 1.074]

Primary

Maximum Observed Concentration (Cmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition

Population: BE analysis Population

Arm	Measure	Value (GEOMETRIC_MEAN)
Paroxetine 40 mg, GSKT- Fed	Maximum Observed Concentration (Cmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition	39.95 Nanogram per milliliter
Paroxetine 40 mg, Mississauga- Fed	Maximum Observed Concentration (Cmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition	39.02 Nanogram per milliliter

90% CI: [0.952, 1.101]

Secondary

DBP and SBP at Indicated Time-points Under Fasting Condition

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.

Time frame: Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 12 (pre-dose)	108.3 Millimeters of mercury	Standard Deviation 10.4
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 15	70.6 Millimeters of mercury	Standard Deviation 7.65
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 16	71.9 Millimeters of mercury	Standard Deviation 7.32
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 1 (post-dose)	107.4 Millimeters of mercury	Standard Deviation 10.56
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 2 (post-dose)	108.1 Millimeters of mercury	Standard Deviation 11.85
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 11	113.2 Millimeters of mercury	Standard Deviation 13.72
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 12 (post-dose)	111.6 Millimeters of mercury	Standard Deviation 9.63
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 13 (post-dose)	111.7 Millimeters of mercury	Standard Deviation 10.5
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 1 (post-dose)	71.8 Millimeters of mercury	Standard Deviation 6.37
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 2 (post-dose)	68.3 Millimeters of mercury	Standard Deviation 7.59
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 3	66.2 Millimeters of mercury	Standard Deviation 6.99
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 4	68.3 Millimeters of mercury	Standard Deviation 8.29
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 5	68.1 Millimeters of mercury	Standard Deviation 6.16
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 11	71.9 Millimeters of mercury	Standard Deviation 6.62
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 12 (pre-dose)	72.6 Millimeters of mercury	Standard Deviation 8
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 12 (post-dose)	73.5 Millimeters of mercury	Standard Deviation 6.29
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 13 (post-dose)	72.6 Millimeters of mercury	Standard Deviation 6.72
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 14	72.2 Millimeters of mercury	Standard Deviation 6.96
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 3	106.3 Millimeters of mercury	Standard Deviation 10.19
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 4	105.1 Millimeters of mercury	Standard Deviation 10.31
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 5	104.4 Millimeters of mercury	Standard Deviation 9.17
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 14	110.5 Millimeters of mercury	Standard Deviation 12.18
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 15	108.5 Millimeters of mercury	Standard Deviation 10.56
Paroxetine 40 mg, GSKT- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 16	110.7 Millimeters of mercury	Standard Deviation 12.7
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 4	68.8 Millimeters of mercury	Standard Deviation 5.91
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 14	70.2 Millimeters of mercury	Standard Deviation 4.76
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 2 (post-dose)	110.1 Millimeters of mercury	Standard Deviation 10.13
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 15	68.7 Millimeters of mercury	Standard Deviation 8.39
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 5	73.3 Millimeters of mercury	Standard Deviation 7.31
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 16	71.1 Millimeters of mercury	Standard Deviation 8.28
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 15	107.4 Millimeters of mercury	Standard Deviation 9.63
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 1 (post-dose)	109.2 Millimeters of mercury	Standard Deviation 10.82
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 11	71.4 Millimeters of mercury	Standard Deviation 7.36
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 5	111.3 Millimeters of mercury	Standard Deviation 12.03
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 3	108.2 Millimeters of mercury	Standard Deviation 12.21
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 11	111.4 Millimeters of mercury	Standard Deviation 12.88
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 2 (post-dose)	68.7 Millimeters of mercury	Standard Deviation 7.61
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 12 (pre-dose)	107.4 Millimeters of mercury	Standard Deviation 9.63
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 12 (pre-dose)	71.2 Millimeters of mercury	Standard Deviation 9.11
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 12 (post-dose)	107.5 Millimeters of mercury	Standard Deviation 8.84
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 14	104.5 Millimeters of mercury	Standard Deviation 9.48
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 13 (post-dose)	109.9 Millimeters of mercury	Standard Deviation 11.86
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 12 (post-dose)	70.3 Millimeters of mercury	Standard Deviation 7.59
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 1 (post-dose)	70.9 Millimeters of mercury	Standard Deviation 6.56
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 4	107.4 Millimeters of mercury	Standard Deviation 8.78
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 13 (post-dose)	69.6 Millimeters of mercury	Standard Deviation 7.22
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	DBP, Day 3	67.8 Millimeters of mercury	Standard Deviation 9.22
Paroxetine 40 mg, Mississauga- Fed	DBP and SBP at Indicated Time-points Under Fasting Condition	SBP, Day 16	104.2 Millimeters of mercury	Standard Deviation 9.65

Secondary

Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition

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.

Time frame: Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 12 (post-dose), n=20,22	69.9 Millimeters of mercury	Standard Deviation 7.71
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 2 (post-dose), n=23,24	69.0 Millimeters of mercury	Standard Deviation 7.93
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 3, n=23,24	67.7 Millimeters of mercury	Standard Deviation 7.11
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 4, n=23,24	67.5 Millimeters of mercury	Standard Deviation 6.68
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 11, n=21,22	69.9 Millimeters of mercury	Standard Deviation 7.62
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 12 (pre-dose), n=21,22	71.2 Millimeters of mercury	Standard Deviation 6.59
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 1 (post-dose), n=23,24	70.4 Millimeters of mercury	Standard Deviation 9.27
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 13 (post-dose), n=20,22	70.3 Millimeters of mercury	Standard Deviation 6.5
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 1 (post-dose), n=23,24	112.4 Millimeters of mercury	Standard Deviation 10.13
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 2 (post-dose), n=23,24	113.8 Millimeters of mercury	Standard Deviation 9.07
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 5, n=23,24	109.2 Millimeters of mercury	Standard Deviation 10.31
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 12 (pre-dose), n=21,22	107.2 Millimeters of mercury	Standard Deviation 9.54
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 16, n=20,22	107.1 Millimeters of mercury	Standard Deviation 8.94
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 5, n=23,24	69.7 Millimeters of mercury	Standard Deviation 6.98
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 14, n=20,22	70.3 Millimeters of mercury	Standard Deviation 8.15
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 15, n=20,22	68.8 Millimeters of mercury	Standard Deviation 6.14
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 16, n=20,22	72.8 Millimeters of mercury	Standard Deviation 8.42
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 3, n=23,24	112.9 Millimeters of mercury	Standard Deviation 9.46
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 4, n=23,24	111.1 Millimeters of mercury	Standard Deviation 10.83
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 11, n=21,22	109.0 Millimeters of mercury	Standard Deviation 10.89
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 12 (post-dose), n=20,22	112.4 Millimeters of mercury	Standard Deviation 9.66
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 13 (post-dose), n=20,22	111.4 Millimeters of mercury	Standard Deviation 10.18
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 14, n=20,22	107.0 Millimeters of mercury	Standard Deviation 9.49
Paroxetine 40 mg, GSKT- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 15, n=20,22	107.3 Millimeters of mercury	Standard Deviation 7.73
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 16, n=20,22	105.9 Millimeters of mercury	Standard Deviation 6.29
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 1 (post-dose), n=23,24	67.8 Millimeters of mercury	Standard Deviation 6.84
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 4, n=23,24	66.1 Millimeters of mercury	Standard Deviation 6.86
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 2 (post-dose), n=23,24	66.8 Millimeters of mercury	Standard Deviation 7.38
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 12 (post-dose), n=20,22	112.4 Millimeters of mercury	Standard Deviation 11.42
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 3, n=23,24	64.5 Millimeters of mercury	Standard Deviation 5.27
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 13 (post-dose), n=20,22	72.9 Millimeters of mercury	Standard Deviation 7.75
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 5, n=23,24	68.9 Millimeters of mercury	Standard Deviation 7.31
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 14, n=20,22	105.5 Millimeters of mercury	Standard Deviation 8.44
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 11, n=21,22	70.5 Millimeters of mercury	Standard Deviation 8.98
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 14, n=20,22	71.7 Millimeters of mercury	Standard Deviation 7.09
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 12 (pre-dose), n=21,22	72.7 Millimeters of mercury	Standard Deviation 7.79
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 11, n=21,22	110.6 Millimeters of mercury	Standard Deviation 9.18
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 12 (post-dose), n=20,22	72.2 Millimeters of mercury	Standard Deviation 7.67
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 15, n=20,22	70.4 Millimeters of mercury	Standard Deviation 7.1
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 12 (pre-dose), n=21,22	108.5 Millimeters of mercury	Standard Deviation 8.34
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 1 (post-dose), n=23,24	111.8 Millimeters of mercury	Standard Deviation 11.15
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	DBP, Day 16, n=20,22	73.9 Millimeters of mercury	Standard Deviation 6.65
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 4, n=23,24	110.9 Millimeters of mercury	Standard Deviation 10.97
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 2 (post-dose), n=23,24	111.0 Millimeters of mercury	Standard Deviation 10.19
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 5, n=23,24	109.8 Millimeters of mercury	Standard Deviation 10.08
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 13 (post-dose), n=20,22	112.0 Millimeters of mercury	Standard Deviation 8.8
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 15, n=20,22	106.0 Millimeters of mercury	Standard Deviation 9.62
Paroxetine 40 mg, Mississauga- Fed	Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition	SBP, Day 3, n=23,24	109.4 Millimeters of mercury	Standard Deviation 10.52

Secondary

Lambda z of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition

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.

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

Arm	Measure	Value (GEOMETRIC_MEAN)
Paroxetine 40 mg, GSKT- Fed	Lambda z of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition	0.0483 Per hour
Paroxetine 40 mg, Mississauga- Fed	Lambda z of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition	0.0494 Per hour

Secondary

Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition

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.

Time frame: Day 16

Population: Safety Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Albumin, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Glucose, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	AST, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Pot, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Calcium, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Pot, To normal or no change	19 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	ALT, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Pot, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Creatinine, To normal or no change	19 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Sodium, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	AST, To normal or no change	19 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Sodium, To normal or no change	19 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Creatinine, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Sodium, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Albumin, To normal or no change	19 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	ALT, To normal or no change	19 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Glucose, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Albumin, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	AST, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	ALP, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	ALP, To normal or no change	19 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	ALP, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Calcium, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Glucose, To normal or no change	19 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Calcium, To normal or no change	19 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Creatinine, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	ALT, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Creatinine, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	ALT, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	ALT, To normal or no change	19 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Albumin, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Albumin, To normal or no change	19 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	ALP, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	ALP, To normal or no change	19 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	ALP, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	AST, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	AST, To normal or no change	19 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	AST, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Calcium, To normal or no change	19 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Calcium, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Creatinine, To normal or no change	19 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Creatinine, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Glucose, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Glucose, To normal or no change	19 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Glucose, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Pot, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Pot, To normal or no change	19 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Pot, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Sodium, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Sodium, To normal or no change	19 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Sodium, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	ALT, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Albumin, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Calcium, To low	0 Participants

Secondary

Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition

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.

Time frame: Day 16

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Pot, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	ALT, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	ALP, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	ALP, To normal or no change	22 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	ALP, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	AST, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Calcium, To normal or no change	22 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Calcium, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Creatinine, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Creatinine, To normal or no change	22 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Creatinine, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Glucose, To normal or no change	22 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Pot, To normal or no change	22 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Sodium, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Sodium, To normal or no change	22 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Sodium, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	ALT, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	ALT, To normal or no change	22 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Albumin, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Albumin, To normal or no change	22 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Albumin, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	AST, To normal or no change	22 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	AST, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Calcium, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Glucose, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Glucose, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Pot, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	ALT, To normal or no change	22 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Sodium, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Albumin, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Albumin, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Calcium, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	ALP, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	ALT, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	ALP, To normal or no change	22 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Creatinine, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	ALP, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	ALT, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Creatinine, To normal or no change	22 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Calcium, To normal or no change	22 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Creatinine, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Calcium, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Albumin, To normal or no change	22 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Pot, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	AST, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Glucose, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Pot, To normal or no change	22 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Glucose, To normal or no change	22 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	AST, To normal or no change	22 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Pot, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Glucose, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Sodium, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	AST, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition	Sodium, To normal or no change	22 Participants

Secondary

Number of Participants With Clinically Significant Abnormal Findings for ECG Parameters Under Fasting Condition

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.

Time frame: Baseline (Day-7 to Day -1) and Day 16

Population: Safety Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Clinically Significant Abnormal Findings for ECG Parameters Under Fasting Condition	Baseline	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Clinically Significant Abnormal Findings for ECG Parameters Under Fasting Condition	Day 16	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Clinically Significant Abnormal Findings for ECG Parameters Under Fasting Condition	Baseline	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Clinically Significant Abnormal Findings for ECG Parameters Under Fasting Condition	Day 16	0 Participants

Secondary

Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters Under Fed Condition

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.

Time frame: Baseline (Day-7 to Day -1) and Day 16

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters Under Fed Condition	Day 16, n=22, 22	1 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters Under Fed Condition	Baseline, n=22, 25	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters Under Fed Condition	Baseline, n=22, 25	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters Under Fed Condition	Day 16, n=22, 22	0 Participants

Secondary

Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition

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.

Time frame: Day 16

Population: Safety Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Hct, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Hb, To normal or no change	19 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Erythrocytes, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Erythrocytes, To low	1 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Hct, To normal or no change	19 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Hb, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Hb, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Platelets, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Platelets, To normal or no change	19 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Erythrocytes, To normal or no change	18 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Platelets, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Hct, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Platelets, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Hct, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Hb, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Hb, To normal or no change	19 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Hb, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Platelets, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Erythrocytes, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Erythrocytes, To normal or no change	19 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Erythrocytes, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Hct, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Hct, To normal or no change	19 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition	Platelets, To normal or no change	19 Participants

Secondary

Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition

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.

Time frame: Day 16

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Erythrocytes, To low	2 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Erythrocytes, To normal or no change	20 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Erythrocytes, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Hct, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Hct, To normal or no change	22 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Hct, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Hb, To normal or no change	22 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Platelets, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Platelets, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Hb, To low	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Hb, To high	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Platelets, To normal or no change	22 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Platelets, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Erythrocytes, To low	2 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Hb, To normal or no change	22 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Erythrocytes, To normal or no change	19 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Hb, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Erythrocytes, To high	1 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Hct, To high	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Hct, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Platelets, To low	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Hct, To normal or no change	22 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Platelets, To normal or no change	22 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition	Hb, To low	0 Participants

Secondary

Number of Participants With Non-SAE and SAEs Under Fasting Condition

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.

Time frame: Up to Day 26

Population: Safety Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Non-SAE and SAEs Under Fasting Condition	Any non-SAEs	12 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Non-SAE and SAEs Under Fasting Condition	Any SAEs	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Non-SAE and SAEs Under Fasting Condition	Any non-SAEs	16 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Non-SAE and SAEs Under Fasting Condition	Any SAEs	0 Participants

Secondary

Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Under Fed Condition

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.

Time frame: Up to Day 26

Population: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Under Fed Condition	Any SAEs	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Under Fed Condition	Any non-SAEs	14 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Under Fed Condition	Any non-SAEs	13 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Under Fed Condition	Any SAEs	0 Participants

Secondary

Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition

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.

Time frame: Baseline (Day-7 to Day -1) and Day 16

Population: Safety Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=6, Day 16	13 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Protein, Day 16, Negative	19 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=6, Baseline	2 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=6.5, Baseline	5 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=7, Baseline	6 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=8, Baseline	3 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=5, Day 16	4 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=6.5, Day 16	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Glucose, Day 16, Negative,	19 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Glucose, Day 16, Positive,	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Ketones, Baseline, Positive	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Ketones, Day 16,Positive	1 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Ketones, Day 16, Negative	18 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Glucose, Baseline, Negative,	19 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Glucose, Baseline, Positive,	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Ketones, Baseline, Negative	19 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Occult blood, Baseline, Positive	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Occult blood, Baseline, Negative	19 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Occult blood, Day 16, Positive	3 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Occult blood, Day 16, Negative	16 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Protein, Baseline, Negative	19 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Protein, Baseline, Positive	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Protein, Day 16, Positive	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=5, Baseline	3 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=7, Day 16	2 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=8, Day 16	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=8, Day 16	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Protein, Day 16, Negative	18 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=7, Day 16	2 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=6, Baseline	3 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Glucose, Baseline, Positive,	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=6.5, Baseline	4 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Glucose, Day 16, Positive,	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=7, Baseline	9 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=5, Baseline	2 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=8, Baseline	1 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Ketones, Baseline, Negative	19 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=5, Day 16	6 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Protein, Baseline, Negative	19 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=6, Day 16	11 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Ketones, Day 16,Positive	1 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Glucose, Baseline, Negative,	19 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Protein, Baseline, Positive	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Glucose, Day 16, Negative,	19 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Occult blood, Baseline, Positive	1 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	pH=6.5, Day 16	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Ketones, Baseline, Positive	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Protein, Day 16, Positive	1 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Occult blood, Day 16, Positive	1 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Ketones, Day 16, Negative	18 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Occult blood, Baseline, Negative	18 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition	Occult blood, Day 16, Negative	18 Participants

Secondary

Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition

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.

Time frame: Baseline (Day-7 to Day -1) and Day 16

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=6.5, Baseline,n=22,25	3 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Glucose, Day 16, Positive, n=22,22	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Ketones, Baseline, Positive, n=22,25	2 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Ketones, Day 16, Positive,n=22,22	1 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Occult blood, Baseline, Negative,n=22,25	20 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Occult blood, Day 16, Positive,n=22,22	5 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Occult blood, Day 16, Negative,n=22,22	17 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Protein, Day 16, Positive,n=22,22	1 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Protein, Day 16, Negative,n=22,22	21 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=6.5, Day 16,n=22,22	4 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Glucose, Baseline, Negative, n=22,25	22 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Glucose, Baseline, Positive, n=22,25	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Ketones, Baseline, Negative, n=22,25	20 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Ketones, Day 16, Negative,n=22,22	21 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Occult blood, Baseline, Positive,n=22,25	2 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Protein, Baseline, Negative,n=22,25	22 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Protein, Baseline, Positive,n=22,25	0 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=5, Baseline,n=22,25	1 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=6, Baseline,n=22,25	7 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Glucose, Day 16, Negative, n=22,22	22 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=7, Baseline,n=22,25	9 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=8, Baseline,n=22,25	2 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=5, Day 16,n=22,22	2 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=6, Day 16,n=22,22	12 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=7, Day 16,n=22,22	4 Participants
Paroxetine 40 mg, GSKT- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=8, Day 16,n=22,22	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=6, Day 16,n=22,22	10 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Ketones, Day 16, Negative,n=22,22	22 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Glucose, Day 16, Positive, n=22,22	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=6.5, Baseline,n=22,25	6 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Ketones, Baseline, Positive, n=22,25	1 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Occult blood, Baseline, Positive,n=22,25	3 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=5, Day 16,n=22,22	4 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Occult blood, Baseline, Negative,n=22,25	22 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Protein, Baseline, Negative,n=22,25	25 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Occult blood, Day 16, Positive,n=22,22	3 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=7, Baseline,n=22,25	10 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Occult blood, Day 16, Negative,n=22,22	19 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Protein, Baseline, Positive,n=22,25	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Protein, Day 16, Positive,n=22,22	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Protein, Day 16, Negative,n=22,22	22 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=8, Day 16,n=22,22	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=6.5, Day 16,n=22,22	2 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=7, Day 16,n=22,22	6 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=5, Baseline,n=22,25	4 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Glucose, Baseline, Negative, n=22,25	25 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=8, Baseline,n=22,25	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Glucose, Baseline, Positive, n=22,25	0 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Glucose, Day 16, Negative, n=22,22	22 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	pH=6, Baseline,n=22,25	5 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Ketones, Baseline, Negative, n=22,25	24 Participants
Paroxetine 40 mg, Mississauga- Fed	Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition	Ketones, Day 16, Positive,n=22,22	0 Participants

Secondary

Pulse Rate (PR) at Indicated Time-points Under Fasting Condition

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.

Time frame: Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 5	67.3 Beats per minute	Standard Deviation 6.82
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 2 (post-dose)	74.8 Beats per minute	Standard Deviation 7.4
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 13 (post-dose)	78.1 Beats per minute	Standard Deviation 11.03
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 3	74.9 Beats per minute	Standard Deviation 8.45
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 11	81.8 Beats per minute	Standard Deviation 9.72
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 14	78.9 Beats per minute	Standard Deviation 11.12
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 12 (pre-dose)	66.5 Beats per minute	Standard Deviation 8.73
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 12 (post-dose)	67.5 Beats per minute	Standard Deviation 8.96
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 15	78.2 Beats per minute	Standard Deviation 8.38
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 1 (post-dose)	65.4 Beats per minute	Standard Deviation 8.8
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 16	75.7 Beats per minute	Standard Deviation 10.39
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 4	74.2 Beats per minute	Standard Deviation 8.74
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 16	71.3 Beats per minute	Standard Deviation 7.92
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 4	72.8 Beats per minute	Standard Deviation 9.86
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 5	71.2 Beats per minute	Standard Deviation 9.6
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 12 (post-dose)	65.2 Beats per minute	Standard Deviation 7.19
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 13 (post-dose)	75.4 Beats per minute	Standard Deviation 7.54
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 14	76.8 Beats per minute	Standard Deviation 8.25
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 1 (post-dose)	67.5 Beats per minute	Standard Deviation 7.19
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 2 (post-dose)	75.3 Beats per minute	Standard Deviation 8.31
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 3	77.2 Beats per minute	Standard Deviation 10.69
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 11	84.1 Beats per minute	Standard Deviation 9.2
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 12 (pre-dose)	66.8 Beats per minute	Standard Deviation 10.48
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fasting Condition	Day 15	75.9 Beats per minute	Standard Deviation 9.58

Secondary

Pulse Rate (PR) at Indicated Time-points Under Fed Condition

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.

Time frame: Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 4, n=23,24	75.5 Beats per minute	Standard Deviation 7.13
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 5, n=23,24	68.7 Beats per minute	Standard Deviation 7.03
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 12 (pre-dose), n=21,22	65.8 Beats per minute	Standard Deviation 9
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 12 (post-dose), n=20,22	72.8 Beats per minute	Standard Deviation 10.85
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 13 (post-dose), n=20,22	73.7 Beats per minute	Standard Deviation 11.86
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 14, n=20,22	75.6 Beats per minute	Standard Deviation 10.72
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 1 (post-dose), n=23,24	72.3 Beats per minute	Standard Deviation 10.57
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 2 (post-dose), n=23,24	72.8 Beats per minute	Standard Deviation 8.22
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 3, n=23,24	74.0 Beats per minute	Standard Deviation 9.11
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 11, n=21,22	75.0 Beats per minute	Standard Deviation 11.05
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 15, n=20,22	77.5 Beats per minute	Standard Deviation 11.33
Paroxetine 40 mg, GSKT- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 16, n=20,22	69.4 Beats per minute	Standard Deviation 8.54
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 15, n=20,22	75.5 Beats per minute	Standard Deviation 8.38
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 4, n=23,24	75.7 Beats per minute	Standard Deviation 11.02
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 1 (post-dose), n=23,24	72.0 Beats per minute	Standard Deviation 8.83
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 5, n=23,24	68.3 Beats per minute	Standard Deviation 8.87
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 11, n=21,22	77.7 Beats per minute	Standard Deviation 8.38
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 12 (pre-dose), n=21,22	64.7 Beats per minute	Standard Deviation 7.57
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 2 (post-dose), n=23,24	74.1 Beats per minute	Standard Deviation 9.98
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 12 (post-dose), n=20,22	76.2 Beats per minute	Standard Deviation 10.15
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 16, n=20,22	72.6 Beats per minute	Standard Deviation 9.51
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 13 (post-dose), n=20,22	73.8 Beats per minute	Standard Deviation 8.07
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 3, n=23,24	75.8 Beats per minute	Standard Deviation 10.07
Paroxetine 40 mg, Mississauga- Fed	Pulse Rate (PR) at Indicated Time-points Under Fed Condition	Day 14, n=20,22	77.6 Beats per minute	Standard Deviation 9.88

Secondary

Respiratory Rate (RR) at Indicated Time-point Under Fed Condition

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.

Time frame: Day 11

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

Arm	Measure	Value (MEAN)	Dispersion
Paroxetine 40 mg, GSKT- Fed	Respiratory Rate (RR) at Indicated Time-point Under Fed Condition	17.8 Breaths per minute	Standard Deviation 1.78
Paroxetine 40 mg, Mississauga- Fed	Respiratory Rate (RR) at Indicated Time-point Under Fed Condition	18.6 Breaths per minute	Standard Deviation 1.79

Secondary

RR at Indicated Time-point Under Fasting Condition

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.

Time frame: Day 11

Population: Safety Population

Arm	Measure	Value (MEAN)	Dispersion
Paroxetine 40 mg, GSKT- Fed	RR at Indicated Time-point Under Fasting Condition	19.2 Breaths per minute	Standard Deviation 1.38
Paroxetine 40 mg, Mississauga- Fed	RR at Indicated Time-point Under Fasting Condition	19.4 Breaths per minute	Standard Deviation 1.16

Secondary

t1/2 of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition

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.

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

Arm	Measure	Value (GEOMETRIC_MEAN)
Paroxetine 40 mg, GSKT- Fed	t1/2 of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition	14.3515 Hours
Paroxetine 40 mg, Mississauga- Fed	t1/2 of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition	14.0311 Hours

Secondary

Temperature at Indicated Time-point Under Fasting Condition

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.

Time frame: Day 11

Population: Safety Population

Arm	Measure	Value (MEAN)	Dispersion
Paroxetine 40 mg, GSKT- Fed	Temperature at Indicated Time-point Under Fasting Condition	36.84 Celsius	Standard Deviation 0.187
Paroxetine 40 mg, Mississauga- Fed	Temperature at Indicated Time-point Under Fasting Condition	36.74 Celsius	Standard Deviation 0.256

Secondary

Temperature at Indicated Time-point Under Fed Condition

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.

Time frame: Day 11

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

Arm	Measure	Value (MEAN)	Dispersion
Paroxetine 40 mg, GSKT- Fed	Temperature at Indicated Time-point Under Fed Condition	36.70 Celsius	Standard Deviation 0.307
Paroxetine 40 mg, Mississauga- Fed	Temperature at Indicated Time-point Under Fed Condition	36.59 Celsius	Standard Deviation 0.333

Secondary

Terminal Elimination Half-life (t1/2) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition

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.

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

Arm	Measure	Value (GEOMETRIC_MEAN)
Paroxetine 40 mg, GSKT- Fed	Terminal Elimination Half-life (t1/2) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition	16.0002 Hours
Paroxetine 40 mg, Mississauga- Fed	Terminal Elimination Half-life (t1/2) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition	14.9913 Hours

Secondary

Terminal Elimination Rate Constant (Lambda z) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition

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.

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

Arm	Measure	Value (GEOMETRIC_MEAN)
Paroxetine 40 mg, GSKT- Fed	Terminal Elimination Rate Constant (Lambda z) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition	0.0433 Per hour
Paroxetine 40 mg, Mississauga- Fed	Terminal Elimination Rate Constant (Lambda z) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition	0.0462 Per hour

Secondary

Time to Reach Maximum Observed Concentration (Tmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition

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.

Population: 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.

Arm	Measure	Value (MEDIAN)
Paroxetine 40 mg, GSKT- Fed	Time to Reach Maximum Observed Concentration (Tmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition	5.00 Hours
Paroxetine 40 mg, Mississauga- Fed	Time to Reach Maximum Observed Concentration (Tmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition	5.00 Hours

Secondary

Tmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition

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.

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

Arm	Measure	Value (MEDIAN)
Paroxetine 40 mg, GSKT- Fed	Tmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition	5.00 Hours
Paroxetine 40 mg, Mississauga- Fed	Tmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition	5.00 Hours

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Bioequivalence Study of Paroxetine Immediate Release (IR) Tablets Manufactured in GlaxoSmithKline Tianjin (GSKT) and Mississauga Sites in Healthy Chinese Subjects

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Area Under the Concentration-time Curve From Administration Extrapolated to the Last Time of Quantifiable Concentration (AUC[0-t]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition

Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition

AUC(0-infinity) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition

AUC(0-t) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition

Cmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition

Maximum Observed Concentration (Cmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition

DBP and SBP at Indicated Time-points Under Fasting Condition

Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition

Lambda z of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition

Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition

Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition

Number of Participants With Clinically Significant Abnormal Findings for ECG Parameters Under Fasting Condition

Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters Under Fed Condition

Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition

Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition

Number of Participants With Non-SAE and SAEs Under Fasting Condition

Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Under Fed Condition

Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition

Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition

Pulse Rate (PR) at Indicated Time-points Under Fasting Condition

Pulse Rate (PR) at Indicated Time-points Under Fed Condition

Respiratory Rate (RR) at Indicated Time-point Under Fed Condition

RR at Indicated Time-point Under Fasting Condition

t1/2 of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition

Temperature at Indicated Time-point Under Fasting Condition

Temperature at Indicated Time-point Under Fed Condition

Terminal Elimination Half-life (t1/2) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition

Terminal Elimination Rate Constant (Lambda z) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition

Time to Reach Maximum Observed Concentration (Tmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition

Tmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition