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The objective of this study is to evaluate relative bioavailability between 80 mg LY03005 oral tablets and 50 mg Pristiq® oral tablets after a single dose of each drug in a cross-over 2-period design under fasting condition in healthy subjects between 18 and 50 years of age.
Fifty six (56) eligible subjects will be enrolled and assigned to either Group A or Group B at a 1:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY03005 cross-over to Pristiq® (Desvenlafaxine) | Experimental | Subjects in this group will receive an 80 mg oral dose of LY03005. After a washout period of up to 4 days, the subjects will be switched and will receive a 50 mg oral dose of desvenlafaxine (Pristiq®). |
|
| Pristiq® (Desvenlafaxine) cross-over to LY03005 | Experimental | Subjects in this group will receive a 50 mg oral dose of desvenlafaxine (Pristiq®) After a washout period of up to 4 days, the subjects will be switched and will receive an 80 mg oral dose of LY03005 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY03005 | Drug | Drug: LY03005 80 mg, oral tablets, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| concentration-time curve (AUC) | Plasma ODV area under the concentration-time curve (AUC) | 15 days |
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Inclusion Criteria:
Highly effective methods of birth control must be used for at least 14 days prior to study drug dosing, through the end of study (EOS) visit or early termination, and for a minimum of 1 month after the last dose of study drug to minimize the risk of pregnancy. Sexually active, fertile, male subjects must be willing to use acceptable contraception methods (such as double-barrier methods of a combination of male condom with either cap, diaphragm, or sponge with spermicide) from the first dose of study drug through the EOS visit or early termination, and for a minimum of 1 month after the last dose of study drug.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Sun, MD, PhD, MBA | Luye Pharma Group Ltd. | Study Chair |
| 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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| Pristiq | Drug | Drug: Pristiq 50 mg, oral tablets, single dose |
|
|
| U.S. FDA Resources | View source |
| Pristiq (Desvenlafaxine) Label - FDA | 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 |