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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)

NCT01190514 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2012-01-27

Study results available
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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.

Conditions

  • Depression - Major Depressive Disorder

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01190514 on ClinicalTrials.gov