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This study compared the relative bioavailability (rate and extent of absorption) of Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited with that of Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd. Distributed by Parke-Davis, division of Warner-Lambert Co. following a single oral dose (1x800 mg tablet) in healthy adult volunteers under non-fasting conditions.
A single oral dose of the test or the reference product was administered to 22 healthy adult human volunteers on two separate occasions under non-fasting conditions with at least a 7 day washout between the doses. Food and the fluid intake were controlled during each confinement period.
Twenty two (22) healthy adult human volunteers (12 males and 10 females) were enrolled in the study. All twenty two (22) subjects successfully completed the clinical portion of the study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited |
|
| 2 | Active Comparator | Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin tablets 800 mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRACS Institute Ltd. | Fargo | North Dakota | 58104 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
| Related Info | View source |
| Related Info |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |