At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 28 enrolled
Drug / intervention
Desvenlafaxine Succinate Sustained Release +1 moredrug
Likely dose
Desvenlafaxine Succinate Sustained Release 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Two-Period, Sequential Drug Interaction Study to Evaluate the Effect of Multiple Doses of Desvenlafaxine Succinate Sustained Release (DVS SR) on the Pharmacokinetics of Midazolam When Coadministered in Healthy Subjects
In Brief
A Phase 4 clinical trial evaluating Desvenlafaxine Succinate Sustained Release and Midazolam for Major Depressive Disorder. Completed, enrolled 28 participants across 1 site.
Detailed Summary
The main purpose of this study is to evaluate the effect of desvenlafaxine administered as DVS SR on the pharmacokinetics of midazolam in healthy male and female subjects. The amount of drug in the body and the effect of the drug will also be evaluated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2009
Enrollment StartJun 2010
Primary CompletionAug 2010
TodayJul 2026
First PostedAug 6, 2009
Enrollment StartJun 1, 2010
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.9 years ago
Interventions
Desvenlafaxine Succinate Sustained Releasedrug
50 mg DVS SR tablet days 1-6, period 2 only.
Midazolamdrug
4 mg midazolam (2 mL midazolam syrup) day 1, period 1 and day 6, period 2.