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To determine the bioequivalence of 2 tablets of 25 mg sustained release (SR) formulation of DVS and 1 tablet of 50 mg SR formulation of DVS under fed and fast conditions.
To investigate the effect of high-fat meal on pharmacokinetics of desvenlafaxine after administration of 50 mg SR formulation of DVS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioequivalence and Food effect | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| desvenlafaxine succinate sustained release | Drug | Two tablets of 25 mg, single administration, under fed condition |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48) | Area under the plasma concentration versus time curve from time zero (pre-dose) to 48 hours post dose; measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL). | Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose |
| Maximum Plasma Concentration (Cmax) | Cmax measured as nanograms divided by milliliters (ng/mL). | Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose | |
| Terminal Elimination Half-life (t 1/2) | Terminal elimination (plasma decay) half-life is the time measured for the plasma concentration to decrease by one half. |
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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 | Brussels | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants randomized to an open-label treatment sequence beginning in Period 1 with 25 milligrams as 2 tablets (25 mg*2) in fed state=A; or a 50 mg tablet in fed state=B; or 25 mg*2 tablets in fasted state=C; or a 50 mg tablet in fasted state=D in a cross-over, 4-period design. Treatment groups sequenced as: ABCD, BADC, CDAB, and DCBA.
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| ID | Title | Description |
|---|---|---|
| FG000 | DVS SR 25 mg*2 Fed (A) First | Desvenlafaxine sustained release (DVS SR) formulation (PF-0212375) 25 milligrams (mg) as 2 tablets (25 mg*2) on Day 1 of study period in fed state (finished a high-fat breakfast 20 minutes prior to dosing). |
| FG001 | DVS SR 50 mg Fed (B) First |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention (Period 1) |
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| desvenlafaxine succinate sustained release | Drug | One tablet of 50 mg, single administration, under fed condition |
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| desvenlafaxine succinate sustained release | Drug | Two tablets of 25 mg, single administration, under fast condition |
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| desvenlafaxine succinate sustained release | Drug | One tablet of 50 mg, single administration, under fast condition |
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| Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose |
| Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) | 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 - ∞). | Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose |
| Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUClast) | Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose |
DVS SR 50 mg tablet on Day 1 of study period in fed state. |
| FG002 | DVS SR 25 mg*2 Fasted (C) First | DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state (fasted 8 hours prior to dosing). |
| FG003 | DVS SR 50 mg Fasted (D) First | DVS SR 50 mg tablet on Day 1 of study period in fasted state. |
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| NOT COMPLETED |
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| Second Intervention (Period 2) |
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| Third Intervention (Period 3) |
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| Fourth Intervention (Period 4) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Participants randomized to 1 of the 4 treatment sequences beginning with DVS SR 25 mg*2 Fed (A); or DVS SR 50 mg Fed (B); or DVS SR 25 mg*2 Fasted (C); or DVS SR 50 mg Fasted (D). |
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48) | Area under the plasma concentration versus time curve from time zero (pre-dose) to 48 hours post dose; measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL). | Pharmacokinetic parameter analysis (PK) population: all participants randomized and treated and had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean. | Posted | Mean | Standard Deviation | ng*hr/mL | Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | PK population; N=number of participants contributing to the median. | Posted | Median | Full Range | hours | Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose |
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| Primary | Maximum Plasma Concentration (Cmax) | Cmax measured as nanograms divided by milliliters (ng/mL). | PK population; N=number of participants contributing to the mean. | Posted | Mean | Standard Deviation | ng/mL | Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose |
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| Secondary | Terminal Elimination Half-life (t 1/2) | Terminal elimination (plasma decay) half-life is the time measured for the plasma concentration to decrease by one half. | PK population; N=number of participants contributing to the median. | Posted | Mean | Standard Deviation | hours | Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose |
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| Secondary | Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) | 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 - ∞). | PK population; N=number of participants contributing to the mean. | Posted | Mean | Standard Deviation | ng*hr/mL | Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose |
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| Secondary | Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUClast) | PK population; N=number of participants contributing to the mean. | Posted | Mean | Standard Deviation | ng*hr/mL | Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose |
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Events collected from the time of informed consent up to 28 days after last dose of study treatment.
Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times due to the transition through the cross-over sequences.
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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 | DVS SR 25 mg*2 Fed | DVS SR 25 mg*2 tablets on Day 1 of study period in fed state (finished a high-fat breakfast 20 minutes prior to dosing). | 0 | 41 | 19 | 41 | ||
| EG001 | DVS SR 50 mg Fed | DVS SR 50 mg tablet on Day 1 of study period in fed state. | 0 | 40 | 19 | 40 | ||
| EG002 | DVS SR 25 mg*2 Fasted | DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state (fasted 8 hours prior to dosing). | 0 | 40 | 19 | 40 | ||
| EG003 | DVS SR 50 mg Fasted | DVS SR 50 mg tablet on Day 1 of study period in fasted state. | 0 | 39 | 16 | 39 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eyelid irritation | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal 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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| Dyspepsia | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Epigastric discomfort | 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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| Salivary hypersecretion | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Hunger | General disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | 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 chest pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Pain in jaw | 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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| Head discomfort | 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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| Somnolence | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Ejaculation delayed | Reproductive system and breast disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Hot flush | Vascular 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.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D000069468 | Desvenlafaxine Succinate |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D008055 | Lipids |
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Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).
| DVS SR 25 mg*2 fed (test); DVS SR 50 mg fed (reference). Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect. | Mixed Models Analysis | ratio (%) of adjusted geometric means | 101.31 | 2-Sided | 90 | 97.17 | 105.64 | Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference). | Yes | Non-Inferiority or Equivalence | Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%). |
| Food effect DVS SR 50 mg fed (test) versus DVS SR 50 mg fasted (reference). Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect. | Mixed Models Analysis | ratio (%) of adjusted geometric means | 108.76 | 2-Sided | 90 | 101.10 | 117.01 | Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference). | Yes | Non-Inferiority or Equivalence | Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%). |
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