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This study will be conducted to evaluate and compare the single oral dose bioavailability of Paroxetine manufactured by GlaxoSmithKline (GSK) Pharmaceuticals S.A. for GlaxoSmithKline México, S.A. de C.V. with that of PAXIL® (Paroxetine) of GlaxoSmithKline, México, S.A. de C.V. in healthy, adult, male and female participants under fasting conditions. Maximum 38 participants will be randomized and dosed. The expected duration of this study will be 12 days including 7 days of washout period in-between each dosing. PAXIL is a registered trademark of GSK group of companies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paroxetine hydrochloride followed by PAXIL | Experimental |
| |
| PAXIL followed by paroxetine hydrochloride | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paroxetine hydrochloride | Drug | Paroxetine hydrochloride will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Paroxetine | Blood samples were collected at indicated time points for the analysis of Cmax of Paroxetine. PK parameters were analyzed using non-compartmental analysis. | Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose |
| Area Under the Concentration-time Curve (AUC) From Time Zero to the Last Measurable Concentration (AUC[0-t]) of Paroxetine | Blood samples were collected at indicated time points for the analysis of AUC(0-t) of Paroxetine. PK parameters were analyzed using non-compartmental analysis. | Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose |
| Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Paroxetine | Blood samples were collected at indicated time points for the analysis of AUC(0-inf) of Paroxetine. PK parameters were analyzed using non-compartmental analysis. | Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose |
| Percentage of AUC (0 to Infinity) Obtained by Extrapolation (%AUCex) of Paroxetine | Blood samples were collected at indicated time points for the analysis of %AUCex of Paroxetine. PK parameters were analyzed using non-compartmental analysis. | Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose |
| Time of the Maximum Measured Plasma Concentration (Tmax) of Paroxetine | Blood samples were collected at indicated time points for the analysis of Tmax of Paroxetine. PK parameters were analyzed using non-compartmental analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is any untoward medical occurrence that may occur in a research participant during clinical research phase of a drug or vaccine but which does not necessarily has a causal relationship with this. SAE is defined as any medical occurrence that, at any dose, put participants's life in risk or results in death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent significant disability/incapacity, is a congenital anomaly/birth defect and other important medical events according to medical or scientific judgement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Monterrey | Nuevo León | 66260 | Mexico |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Total 38 participants were enrolled in the study across one study center in Mexico.
This was a single-dose, randomized, balanced, open-label, two-sequence, two-treatment, two-period, crossover bioequivalence study of Paroxetine tablets 20 milligrams (mg) of GlaxoSmithKline (GSK) Pharmaceuticals S.A, with that of PAXIL (Paroxetine) tablets 20 mg of GSK México S.A. de C.V., in healthy adult male & female participants under fasting conditions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paroxetine 20 mg (A) Followed by Paxil 20 mg (B) | Participants received Paroxetine 20 mg tablet (Test drug A) as a single oral dose in treatment period 1. In treatment period 2, participants received Paxil 20 mg tablet (Reference drug B) as a single oral dose. There was a washout period of atleast 7 days between two treatment periods. |
| FG001 | Paxil 20 mg (B) Followed by Paroxetine 20 mg (A) | Participants received Paxil 20 mg tablet (Reference drug B) as a single oral dose in treatment period 1. In treatment period 2, participants received Paroxetine 20 mg tablet (Test drug A) as a single oral dose. There was a washout period of atleast 7 days between two treatment periods. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Up to Day 3) |
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| ||||||||||||||||||
| Washout Period (Up to Day 7) |
| |||||||||||||||||||
| Period 2 (Up to Day 3) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paroxetine 20 mg (A) Followed by Paxil 20 mg (B) | Participants received Paroxetine 20 mg tablet (Test drug A) as a single oral dose in treatment period 1. In treatment period 2, participants received Paxil 20 mg tablet (Reference drug B) as a single oral dose. There was a washout period of atleast 7 days between two treatment periods. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Paroxetine | Blood samples were collected at indicated time points for the analysis of Cmax of Paroxetine. PK parameters were analyzed using non-compartmental analysis. | Pharmacokinetic (PK) analysis set included participants who completed both period of the study as per protocol criteria. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Nanograms per milliliter | Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose |
|
All-cause mortality, non-serious AEs and Serious AEs were collected up to 25 days
All-cause mortality, non-serious AEs and SAEs were collected in safety analysis set. Safety analysis set included all participants who received at least one dose of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paroxetine 20 mg (Test A) | Participants received Paroxetine 20 mg (Test A) as a single oral dose in fasting condition in Periods 1 and 2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2020 | Nov 10, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 21, 2021 | Nov 10, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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A single-dose, randomized, balanced, open-label, two-sequence, two-treatment, two-period, crossover bioequivalence study under fasting condition.
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This is an open-label study.
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| PAXIL (Paroxetine hydrochloride ) | Drug | PAXIL will be administered. |
|
| Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose |
| Elimination Half-life (t1/2) of Paroxetine | Blood samples were collected at indicated time points for the analysis of t1/2 of Paroxetine. PK parameters were analyzed using non-compartmental analysis. | Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose |
| Terminal Elimination Rate Constant (Kel) of Paroxetine | Blood samples were collected at indicated time points for the analysis of Kel of Paroxetine. PK parameters were analyzed using non-compartmental analysis. | Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose |
| Up to 25 days |
| Number of Participants With Abnormal Vital Signs | Systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate, respiration rate and body temperature were measured in semi-supine position after 5 minutes rest. The clinically acceptable range included; SBP: 85 millimeters of mercury (mmHg) to 160 mmHg; DBP: 45 mmHg to 100 mmHg; pulse rate: 40 beats per minute to 110 beats per minute; respiration rate: 8 breaths per minute to 20 breaths per minute; body temperature: 35.5 degrees Celsius to 37.8 degrees Celsius. Number of participants with any abnormality in vital signs are presented. Data is presented treatment wise. | Up to 25 days |
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| NOT COMPLETED |
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|
| BG001 |
| Paxil 20 mg (B) Followed by Paroxetine 20 mg (A) |
Participants received Paxil 20 mg tablet (Reference drug B) as a single oral dose in treatment period 1. In treatment period 2, participants received Paroxetine 20 mg tablet (Test drug A) as a single oral dose. There was a washout period of atleast 7 days between two treatment periods. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Paroxetine 20 mg (Reference B) |
Participants received Paxil (Paroxetine) 20 mg (Reference B) as a single oral dose in fasting condition in Periods 1 and 2. |
|
|
| Primary | Area Under the Concentration-time Curve (AUC) From Time Zero to the Last Measurable Concentration (AUC[0-t]) of Paroxetine | Blood samples were collected at indicated time points for the analysis of AUC(0-t) of Paroxetine. PK parameters were analyzed using non-compartmental analysis. | PK analysis set. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Hour*nanograms per milliliter | Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose |
|
|
|
| Primary | Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Paroxetine | Blood samples were collected at indicated time points for the analysis of AUC(0-inf) of Paroxetine. PK parameters were analyzed using non-compartmental analysis. | PK analysis set. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Hour*nanograms per milliliter | Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose |
|
|
|
| Primary | Percentage of AUC (0 to Infinity) Obtained by Extrapolation (%AUCex) of Paroxetine | Blood samples were collected at indicated time points for the analysis of %AUCex of Paroxetine. PK parameters were analyzed using non-compartmental analysis. | PK analysis set. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Percentage of AUCex | Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose |
|
|
|
| Primary | Time of the Maximum Measured Plasma Concentration (Tmax) of Paroxetine | Blood samples were collected at indicated time points for the analysis of Tmax of Paroxetine. PK parameters were analyzed using non-compartmental analysis. | PK analysis set. Only those participants with data available at the specified data points were analyzed. | Posted | Median | Full Range | Hours | Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose |
|
|
|
| Primary | Elimination Half-life (t1/2) of Paroxetine | Blood samples were collected at indicated time points for the analysis of t1/2 of Paroxetine. PK parameters were analyzed using non-compartmental analysis. | PK analysis set. Only those participants with data available at the specified data points were analyzed. | Posted | Median | Full Range | Hours | Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose |
|
|
|
| Primary | Terminal Elimination Rate Constant (Kel) of Paroxetine | Blood samples were collected at indicated time points for the analysis of Kel of Paroxetine. PK parameters were analyzed using non-compartmental analysis. | PK analysis set. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Per hour | Pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose |
|
|
|
| Secondary | Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is any untoward medical occurrence that may occur in a research participant during clinical research phase of a drug or vaccine but which does not necessarily has a causal relationship with this. SAE is defined as any medical occurrence that, at any dose, put participants's life in risk or results in death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent significant disability/incapacity, is a congenital anomaly/birth defect and other important medical events according to medical or scientific judgement. | Safety analysis set included all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to 25 days |
|
|
|
| Secondary | Number of Participants With Abnormal Vital Signs | Systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate, respiration rate and body temperature were measured in semi-supine position after 5 minutes rest. The clinically acceptable range included; SBP: 85 millimeters of mercury (mmHg) to 160 mmHg; DBP: 45 mmHg to 100 mmHg; pulse rate: 40 beats per minute to 110 beats per minute; respiration rate: 8 breaths per minute to 20 breaths per minute; body temperature: 35.5 degrees Celsius to 37.8 degrees Celsius. Number of participants with any abnormality in vital signs are presented. Data is presented treatment wise. | Safety analysis set. | Posted | Count of Participants | Participants | Up to 25 days |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 7 |
| 38 |
| EG001 | Paroxetine 20 mg (Reference B) | Participants received Paxil (Paroxetine) 20 mg (Reference B) as a single oral dose in fasting condition in Periods 1 and 2. | 0 | 38 | 0 | 38 | 7 | 38 |
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Nausea | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial