Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet

Study Overview
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Brief Summary
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To evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in Korean healthy subjects and compare to westerners.

Official Title
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A Phase 1, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, Parallel-Group, Single and Multiple-Dose Study of Desvenlafaxine in Korean Healthy Subjects

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: desvenlafaxine
* Drug: desvenlafaxine
* Drug: desvenlafaxine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects Between the ages of 18 and 55 years, inclusive Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) Exclusion Criteria: Elevated risk of suicide, in the opinion of the investigator or expert consultant Pregnant or nursing females Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50 mg<br> | Drug: desvenlafaxine<br>* one 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days<br>|
| Experimental: 100 mg<br> | Drug: desvenlafaxine<br>* one 100 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days<br>|
| Experimental: 200 mg<br> | Drug: desvenlafaxine<br>* two 100 mg desvenlafaxine succinate sustained-release tablets or matching placebo, single dose and once daily dose for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For single dose: maximum concentration (Cmax) |  | day 1 | 
| For single dose: time to first occurence of Cmax (Tmax) |  | day 1 | 
| For single dose: area under curve (0-time for last quantifiable concentration) (AUClast) |  | day 1 | 
| For multiple dose: maximum concentration (Cmax) |  | day 8 | 
| For multiple dose: time to first occurence of Cmax (Tmax) |  | day 8 | 
| For multiple dose: trough concentration (Ctrough) |  | day 8 | 
| For multiple dose: area under curve (0-24hours) (AUC0-24) |  | day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For single dose if data permit: terminal elimination half life (t1/2) |  | day 1 | 
| For single dose if data permit: area under curve (0-infinity) (AUCinf) |  | day 1 | 
| For single dose if data permit: oral clearance (CL/F) |  | day 1 | 
| For single dose if data permit: apparent volume of distribution (Vz/F) |  | day 1 | 
| For multiple dose if data permit: accumulation factor (Rac) |  | day 8 | 
| For multiple dose if data permit: terminal elimination half life (t1/2) |  | day 8 | 
| For multiple dose if data permit: oral clearance (CL/F) |  | day 8 | 
| For multiple dose if data permit: apparent volume of distribution (Vz/F) |  | day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, safety, desvenlafaxine, Korean healthy subjects