At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating desvenlafaxine succinate sustained release for Depression - Major Depressive Disorder. Completed, enrolled 41 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Two tablets of 25 mg, single administration, under fed condition
One tablet of 50 mg, single administration, under fed condition
Two tablets of 25 mg, single administration, under fast condition
One tablet of 50 mg, single administration, under fast condition