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)
Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression - Major Depressive Disorder
Intervention: desvenlafaxine succinate sustained release (Drug); desvenlafaxine succinate sustained release (Drug); desvenlafaxine succinate sustained release (Drug); desvenlafaxine succinate sustained release (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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.
Clinical Details
Official title: 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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: AUC48 and Cmax 25 mg×2 tab and 50 mg DVS SR under fed and fast condition.
Secondary outcome: Tmax, AUCinf, AUClast and half-life of desvenlafaxine.Safety laboratory tests, vital signs, suicidality assessment and adverse events.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, Bruxelles B-1070, Belgium; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: August 2010
Last updated: September 16, 2010
|
