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)

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2010

Interventions

  • Drug: desvenlafaxine succinate sustained release
    • Two tablets of 25 mg, single administration, under fed condition
  • Drug: desvenlafaxine succinate sustained release
    • One tablet of 50 mg, single administration, under fed condition
  • Drug: desvenlafaxine succinate sustained release
    • Two tablets of 25 mg, single administration, under fast condition
  • Drug: desvenlafaxine succinate sustained release
    • One tablet of 50 mg, single administration, under fast condition

Arms, Groups and Cohorts

  • Experimental: Bioequivalence and Food effect

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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