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This study is designed to determine differences in drug exposure in subjects after being administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure after administering 50 mg capsules of sertraline hydrochloride under fasted (nonfed) conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sertraline 50 mg capsules | Active Comparator |
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| Sertraline 50 mg tablet | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sertraline hydrochloride | Drug | 50 mg capsule, single-dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to 72 Hours [AUC (0-72)] | AUC (0-72)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours (0-72). | Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose |
| Maximum Observed Plasma Concentration (Cmax) | Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose | |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] | AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Singapore | 188770 | Singapore |
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| Label | URL |
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| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sertraline 50 mg Capsule, Then Sertraline 50 mg Tablet | Sertraline Hydrochloride 50 milligram (mg) hard gelatin capsule in the first intervention period, Sertraline Hydrochloride 50 mg Film-Coated Tablet in the second intervention period |
| FG001 | Sertraline 50 mg Tablet, Then Sertraline 50 mg Capsule |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention |
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| sertraline hydrochloride | Drug | 50 mg tablet, single-dose |
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| Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose |
| Residual Area Under the Concentration Time Curve [AUC(Res%)] | AUC(res%) is the residual AUC defined as (AUCinf minus AUClast) divided by AUCinf. AUCinf is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. AUClast is the area under the plasma concentration-time curve from zero to the last measured concentration. | Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose |
Sertraline Hydrochloride 50 mg film-coated tablet in the first intervention period, Sertraline Hydrochloride 50 mg hard gelatin capsule in the second intervention period |
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| NOT COMPLETED |
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| Washout Period of At Least 8 Days |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Entire study population receiving Sertraline Hydrochloride 50 mg as either hard gelatin capsule or film-coated tablet |
| Units | Counts |
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| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Area Under the Curve From Time Zero to 72 Hours [AUC (0-72)] | AUC (0-72)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours (0-72). | All participants: all treated participants with at least one sertraline concentration were evaluated for pharmacokinetics. | Posted | Mean | Standard Deviation | nanogram hour per milliliter (ng*h/mL) | Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Primary | Maximum Observed Plasma Concentration (Cmax) | All participants. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | All participants. | Posted | Median | Full Range | hours | Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] | AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). | All participants. | Posted | Mean | Standard Deviation | ng*h/mL | Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | Residual Area Under the Concentration Time Curve [AUC(Res%)] | AUC(res%) is the residual AUC defined as (AUCinf minus AUClast) divided by AUCinf. AUCinf is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. AUClast is the area under the plasma concentration-time curve from zero to the last measured concentration. | This parameter was not analyzed. It is reported individually for each subject and not analyzed statistically. | Posted | Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | All participants. | Posted | Mean | Standard Deviation | hours | Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose |
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The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
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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 | Sertraline 50 mg Hard Gelatin Capsule | All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule | 0 | 30 | 11 | 30 | ||
| EG001 | Sertraline 50 mg Film-Coated Tablet | All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet | 0 | 30 | 13 | 30 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Palpitations | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Catheter site haematoma | General disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
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| Superiority or Other (legacy) |
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