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The objective if this study is to assess the relative bio-availability of single oral doses of 80 mg LY03005 tablets administered to healthy subjects under fed versus fasted conditions in a 2-period, crossover trial.
Thirty-two (32) eligible healthy subjects between ages of 18-50 years old will be enrolled and randomized to either Sequence 1 (fed to fasted state) versus Sequence 2 (fasted to fed state) at a 1:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: LY03005 Fed Crossover to Fasted | Experimental | Sequence 1 will receive a single oral dose of LY03005 (80 mg) under fed conditions in Treatment Period 1 and a single oral dose of LY03005 (80 mg) under fasted conditions in Treatment Period 2. |
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| Sequence 2: LY03005 Fasted Crossover to Fed | Experimental | Sequence 2 will receive a single oral dose of LY03005 (80 mg) under fasted conditions in Treatment Period 1 and a single oral dose of LY03005 (80 mg) under fed conditions in Treatment Period 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY03005 | Drug | 80 mg oral tablet single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameters | Area under the concentration-time curve (AUC) | PK samples drawn at predose (within 30 minutes prior to dosing) and at 1, 2, 3, 4 (±5 minutes), 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours (±15 minutes) after the dose. |
| Pharmacokinetic Parameters | Maximum concentration (Cmax) for the Pharmacokinetics (PK) of O-desmethyl-venlafaxine (ODV) from LY03005 | PK samples drawn at predose (within 30 minutes prior to dosing) and at 1, 2, 3, 4 (±5 minutes), 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours (±15 minutes) after the dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Booth, MD, DVM | Luye Pharma. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaron CPC, Inc. | Baltimore | Maryland | 21201 | United States |
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| Label | URL |
|---|---|
| Drug information | View source |
| Desvenlafaxine | View source |
| Desvenlafaxine Succinate |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| 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 |
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| U.S. FDA Resources | View source |
| Organic Chemicals |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D008055 | Lipids |