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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50 mg | Experimental |
| |
| 100 mg | Experimental |
| |
| 200 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| desvenlafaxine | Drug | one 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Seoul | 110-744 | South Korea |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| desvenlafaxine | Drug | one 100 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days |
|
| desvenlafaxine | Drug | two 100 mg desvenlafaxine succinate sustained-release tablets or matching placebo, single dose and once daily dose for 5 days |
|
| 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 |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069468 | Desvenlafaxine Succinate |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D008055 | Lipids |
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