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)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Depression - Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bioequivalence and Food effect

Group Type EXPERIMENTAL

desvenlafaxine succinate sustained release

Intervention Type DRUG

Two tablets of 25 mg, single administration, under fed condition

desvenlafaxine succinate sustained release

Intervention Type DRUG

One tablet of 50 mg, single administration, under fed condition

desvenlafaxine succinate sustained release

Intervention Type DRUG

Two tablets of 25 mg, single administration, under fast condition

desvenlafaxine succinate sustained release

Intervention Type DRUG

One tablet of 50 mg, single administration, under fast condition

Interventions

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desvenlafaxine succinate sustained release

Two tablets of 25 mg, single administration, under fed condition

Intervention Type DRUG

desvenlafaxine succinate sustained release

One tablet of 50 mg, single administration, under fed condition

Intervention Type DRUG

desvenlafaxine succinate sustained release

Two tablets of 25 mg, single administration, under fast condition

Intervention Type DRUG

desvenlafaxine succinate sustained release

One tablet of 50 mg, single administration, under fast condition

Intervention Type DRUG

Other Intervention Names

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DVS-233 SR, Pristiq DVS-233 SR, Pristiq DVS-233 SR, Pristiq DVS-233 SR, Pristiq

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes