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The objective of this study is to evaluate the human bioequivalence of two Venlafaxine Hydrochloride Sustained-Release Capsules (75 mg) .
The objective of this study is to evaluate the human bioequivalence of Venlafaxine Hydrochloride Sustained-Release Capsules (75 mg) produced by Beijing Winsunny Pharmaceutical Co., Ltd and EFEXOR® XR (75mg) produced by Pfizer Ireland Pharmaceuticals(held by Pfizer Healthcare Ireland, distributed by Wyeth pharmaceutical co. LTD), as well as the safety of the tested preparation, and to provide basis for the evaluation of the quality and efficacy consistency of the tested preparation and the reference preparation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venlafaxine Hydrochloride Sustained-Release Capsules | Experimental | During the study session, healthy subjects will be administered a single dose of Hydrochloride Sustained-Release Capsules 75 mg under Fed conditions. |
|
| Active Comparator: EFEXOR® XR | Active Comparator | During the study session, healthy subjects will be administered a single dose of EFEXOR® XR 75mg under Fed conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venlafaxine Hydrochloride Sustained-Release Capsules 75 mg | Drug | A generic product manufactured by Beijing Winsunny Pharmaceutical Co., Ltd. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence based on Cmax | Cmax - Maximum Observed Concentration (of Venlafaxine in Plasma) | Blood samples collected over 72 hour period |
| Bioequivalence based on AUC0-t | AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) | Blood samples collected over 72 hour period |
| Bioequivalence based on AUC0-∞ | AUC0-∞- Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) | Blood samples collected over 72 hour period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Wu, Dr | Contact | 0086-10-58268486 | trdrug@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiuli Zhao, Dr | Beijing Tongren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institution of Drug Clinical Trials | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D000069470 | Venlafaxine Hydrochloride |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| EFEXOR® XR | Drug | EFEXOR® XR (75mg) produced by Pfizer Ireland Pharmaceuticals(held by Pfizer Healthcare Ireland, distributed by Wyeth pharmaceutical co. LTD) |
|
| Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |