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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).
Full 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), fasted administration in healthy volunteers for both genders.
The study is 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 not 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 concentration of drug 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 fasting period. 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 | Reference drug administration followed by test drug administration |
|
| Paxil CR Test | Active Comparator | Test drug administration followed by Reference drug administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test formulation | Drug | Paroxetine Hydrochloride 25 miligrams (mg) tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve_steady-state | 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_steady-state (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, nanogram; 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_steady-state | Cmin_steady-state (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_steady-state | Cmax_steady-state (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 113939 can be found on the GSK Clinical Study Register. | View source |
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All candidates are informed about the study, and all undergo clinical screening.
Recruitment is conducted in accordance with internal Standard Operating Procedures of the research center and with the consent of the participants (Term of Recruitment and Informed Consent Form).
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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), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg, once a day, 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, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra in Period 1; followed by test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| 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, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg, once a day, 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 |
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| 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 | Area Under the Curve_steady-state | 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_steady-state (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, nanogram; h, hour; ml, milliliter. ng.h/ml, nanograms per hour per milliliter. | Participants who completed the study | 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, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg, once a day, 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 |
|---|---|---|---|---|---|
| Fever | General disorders | ds Navigator | Systematic Assessment |
The number of adverse events per intervention is not available in the final report.
| 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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| Reference formulation | Drug | Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation) |
|
| NOT COMPLETED |
|
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Reference Product |
Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra in both periods |
|
|
|
| Primary | Cmin_steady-state | Cmin_steady-state (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. | Participants who completed the study | Posted | Mean | Standard Deviation | ng/ml | Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2) |
|
|
|
|
| Primary | Cmax_steady-state | Cmax_steady-state (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. | Participants who completed the study | Posted | Mean | Standard Deviation | ng/ml | Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2) |
|
|
|
|
| 0 |
| 60 |
| 42 |
| 60 |
| EG001 | Period 2 | Participants receiving test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2 | 0 | 59 | 13 | 59 |
| Cephalea | General disorders | ds Navigator | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
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| Heartburn | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
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| Stomach-ache | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
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| Xerostomia | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
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| Sore throat | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
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| Abdominal colic | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
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| Epigastric pain | Gastrointestinal disorders | ds Navigator | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | ds Navigator | Systematic Assessment |
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| Somnolence | Nervous system disorders | ds Navigator | Systematic Assessment |
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| Sleep disturbances | Nervous system disorders | ds Navigator | Systematic Assessment |
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| Insomnia | Nervous system disorders | ds Navigator | Systematic Assessment |
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| Tremor | Nervous system disorders | ds Navigator | Systematic Assessment |
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| Dizziness | Nervous system disorders | ds Navigator | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal 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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| Mydriasis | Eye disorders | ds Navigator | Systematic Assessment |
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| Tonsillitis | Infections and infestations | ds Navigator | Systematic Assessment |
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| Menstrual pain | Reproductive system and breast disorders | ds Navigator | Systematic Assessment |
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| Knee pain | Social circumstances | ds Navigator | Systematic Assessment |
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| Fracture right upper limb | Social circumstances | 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.