Phase 1
Completed N=41
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)
Depression - Major Depressive Disorder
Source: ClinicalTrials.gov NCT01190514 ↗
Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcomePrimary: Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48) — 2948; 2966; 2632; 2777 ng*hr/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48) |
2948; 2966; 2632; 2777 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) |
130.6; 131.0; 107.3; 112.1 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
6.00; 8.00; 6.00; 6.00 | — |
| SECONDARY Terminal Elimination Half-life (t 1/2) |
10.50; 10.72; 12.71; 11.13 | — |
| SECONDARY Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) |
3171; 3216; 3008; 3052 | — |
| SECONDARY Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUClast) |
2948; 2966; 2631; 2778 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01190514). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.