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Trial record 42 of 89 for:    DESVENLAFAXINE

Phase 1 Study To Test the Bioequivalence Between Two 25 mg Tablets vs. One 50 mg Tablet Under Fast/Fed Condition and Evaluate Food Effect of Desvenlafaxine Succinate Sustained Release (DVS SR)

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ClinicalTrials.gov Identifier: NCT01190514
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : January 27, 2012
Last Update Posted : January 27, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 24, 2010
First Posted Date  ICMJE August 27, 2010
Results First Submitted Date  ICMJE December 21, 2011
Results First Posted Date  ICMJE January 27, 2012
Last Update Posted Date January 27, 2012
Study Start Date  ICMJE September 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
  • Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48) [ Time Frame: 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 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).
  • Maximum Plasma Concentration (Cmax) [ Time Frame: 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 ]
    Cmax measured as nanograms divided by milliliters (ng/mL).
Original Primary Outcome Measures  ICMJE
 (submitted: August 26, 2010)
AUC48 and Cmax 25 mg×2 tab and 50 mg DVS SR under fed and fast condition. [ Time Frame: 2 months ]
Change History Complete list of historical versions of study NCT01190514 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 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) [ Time Frame: 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 (plasma decay) half-life is the time measured for the plasma concentration to decrease by one half.
  • Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) [ Time Frame: 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 versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
  • Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUClast) [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2010)
  • Tmax, AUCinf, AUClast and half-life of desvenlafaxine. [ Time Frame: 2 months ]
  • Safety laboratory tests, vital signs, suicidality assessment and adverse events. [ Time Frame: 2 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study To Test the Bioequivalence Between Two 25 mg Tablets vs. One 50 mg Tablet Under Fast/Fed Condition and Evaluate Food Effect of Desvenlafaxine Succinate Sustained Release (DVS SR)
Official Title  ICMJE Phase 1, Open-Label, Randomized, Single-Dose, 4-Treatment, 4-Period Crossover Bioequivalence Study Comparing 25 Mg and 50 Mg Formulations of DVS-233 SR and Investigate Food Effect on 50 Mg Formulations of DVS-233 SR Tablet Under Fed and Fasted Conditions
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depression - Major Depressive Disorder
Intervention  ICMJE
  • Drug: desvenlafaxine succinate sustained release
    Two tablets of 25 mg, single administration, under fed condition
    Other Name: DVS-233 SR, Pristiq
  • Drug: desvenlafaxine succinate sustained release
    One tablet of 50 mg, single administration, under fed condition
    Other Name: DVS-233 SR, Pristiq
  • Drug: desvenlafaxine succinate sustained release
    Two tablets of 25 mg, single administration, under fast condition
    Other Name: DVS-233 SR, Pristiq
  • Drug: desvenlafaxine succinate sustained release
    One tablet of 50 mg, single administration, under fast condition
    Other Name: DVS-233 SR, Pristiq
Study Arms  ICMJE Experimental: Bioequivalence and Food effect
Interventions:
  • Drug: desvenlafaxine succinate sustained release
  • Drug: desvenlafaxine succinate sustained release
  • Drug: desvenlafaxine succinate sustained release
  • Drug: desvenlafaxine succinate sustained release
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2011)
41
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2010)
40
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and female subjects.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01190514
Other Study ID Numbers  ICMJE B2061035
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP