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The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the test drug and the reference drug (two periods of drug administration after standardized meals).
Title: Relative bioavailability study between the formulations: Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation) and Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation), fed administration in healthy volunteers of both genders.
The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the drug test and reference (two periods of drug administration). The population is composed of 60 healthy volunteers, adult of both gender, with age between 18 and 40 years, with a body mass index (BMI) between 18.5 and 27. Volunteers have weight above than 50 kg. 50% of the volunteers recruited are female and 50% male. There are no restrictions regarding the ethnic group.
The relative bioavailability of the formulations after oral administration in steady state will be evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from data of drug concentration in blood. The concentration of Paroxetine hydrochloride (controlled release) will be measured by an appropriate analytical method and valid after the drug administration.The Pharmacokinetic samples will be collected at steady state in each period after standardized meals. The safety assessment will include evaluation and clinical monitoring, vital signs monitoring, ECG, and laboratory tests. Adverse events will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paxil CR Reference | Active Comparator | Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico, in Period 1, followed by Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada, in Period 2 |
|
| Paxil CR Test | Active Comparator | Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada, in Period 1, followed by Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico, in Period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico | Drug | Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC_ss | The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC_ss is the area under the curve during the steady-state period. The AUC_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; h, hour; ml, milliliter; ng.h/ml, nanograms per hour per milliliter. | Days 14 to 17 (period 1) and Days 23 to 24 (Period 2) |
| Cmin_ss | Cmin_ss is defined as the minimum concentration of a drug observed after its administration, in steady-state. Cmin_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses. | Days 14 to 17 (period 1) and Days 23 to 24 (Period 2) |
| Cmax_ss | Cmax_ss is defined as the maximum or "peak" concentration of a drug observed after its administration, in steady-state. Cmax_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. | Days 14 to 17 (period 1) and Days 23 to 24 (Period 2) |
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EXCLUSION CRITERIA:
INCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Belo Horizonte | Minas Gerais | 30110-014 | Brazil |
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| Label | URL |
|---|---|
| Results for study 114035 can be found on the GSK Clinical Study Register. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product in Period 1; Reference Product in Period 2 | Test product: paroxetine hydrochloride tablet with controlled release (Paxil CR) 25 milligrams (mg) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2 |
| FG001 | Reference Product in Period 1; Test Product in Period 2 | Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1; followed by test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Receiving Both Test and Reference Product | Participants receiving either test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2 or reference product in Period 1 and test product in Period 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | AUC_ss | The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC_ss is the area under the curve during the steady-state period. The AUC_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; h, hour; ml, milliliter; ng.h/ml, nanograms per hour per milliliter. | Entire study population | Posted | Mean | Standard Deviation | ng.h/ml | Days 14 to 17 (period 1) and Days 23 to 24 (Period 2) |
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In order to simplify and avoid errors, the adverse events were separated by periods, not by sequences, due to the large number of adverse events.
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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 | Period 1 | Participants receiving test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | ds Navigator | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| 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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|
| Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada | Drug | Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation) |
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| NOT COMPLETED |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods |
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|
|
| Primary | Cmin_ss | Cmin_ss is defined as the minimum concentration of a drug observed after its administration, in steady-state. Cmin_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses. | Entire study population | Posted | Mean | Standard Deviation | ng/ml | Days 14 to 17 (period 1) and Days 23 to 24 (Period 2) |
|
|
|
|
| Primary | Cmax_ss | Cmax_ss is defined as the maximum or "peak" concentration of a drug observed after its administration, in steady-state. Cmax_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. | Entire study population | Posted | Mean | Standard Deviation | ng/ml | Days 14 to 17 (period 1) and Days 23 to 24 (Period 2) |
|
|
|
|
| 0 |
| 60 |
| 48 |
| 60 |
| EG001 | Period 2 | Participants receiving test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2 | 0 | 60 | 20 | 60 |
| Mydriasis | Eye disorders | ds Navigator | Systematic Assessment |
|
| Watery stools | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
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| Epigastralgia | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
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| Heartburn | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
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| Intestinal colic | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
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| Mild retch | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
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| Cephalea | General disorders | ds Navigator | Systematic Assessment |
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| Fever | General disorders | ds Navigator | Systematic Assessment |
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| Malaise | General disorders | ds Navigator | Systematic Assessment |
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| Weakness | General disorders | ds Navigator | Systematic Assessment |
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| Pain on the whole body | General disorders | ds Navigator | Systematic Assessment |
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| Hyporexia | Metabolism and nutrition disorders | ds Navigator | Systematic Assessment |
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| Lack of appetite | Metabolism and nutrition disorders | ds Navigator | Systematic Assessment |
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| Somnolence | Nervous system disorders | ds Navigator | Systematic Assessment |
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| Insomnia | Nervous system disorders | ds Navigator | Systematic Assessment |
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| Dizziness | Nervous system disorders | ds Navigator | Systematic Assessment |
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| Tremor | Nervous system disorders | ds Navigator | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | ds Navigator | Systematic Assessment |
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| Thinking abnormal | Nervous system disorders | ds Navigator | Systematic Assessment |
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| Sensation of slowness | Nervous system disorders | ds Navigator | Systematic Assessment |
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| Irritability | Psychiatric disorders | ds Navigator | Systematic Assessment |
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| Agitation | Psychiatric disorders | ds Navigator | Systematic Assessment |
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| Menstrual colic | Reproductive system and breast disorders | ds Navigator | Systematic Assessment |
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| Retardation of ejaculation | Reproductive system and breast disorders | ds Navigator | Systematic Assessment |
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| Ejaculation difficulty | Reproductive system and breast disorders | ds Navigator | Systematic Assessment |
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| Sinusitis | Respiratory, thoracic and mediastinal disorders | ds Navigator | Systematic Assessment |
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| Sore throat without evidence of infection | Respiratory, thoracic and mediastinal disorders | ds Navigator | Systematic Assessment |
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| Sore throat with hyperaemia in tonsils | Respiratory, thoracic and mediastinal disorders | ds Navigator | Systematic Assessment |
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| Tonsillitis | Infections and infestations | ds Navigator | Systematic Assessment |
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| Perspiration | Skin and subcutaneous tissue disorders | ds Navigator | Systematic Assessment |
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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.