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This study compared the relative bioavailability (rate and extent of absorption) of the test Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited to the reference Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd., distributed by Parke Davis, division of Warner-Lambert Co. in 28 healthy, adult subjects (21 males and 7 females) under fasting conditions using randomized, two-way crossover design.
A single oral dose of the test or reference product was administered to the volunteers on two separate occasions under fasting conditions with at least a 7 day washout between doses. Food and fluid intake were controlled during each confinement period.
A total of twenty eight (28) healthy subjects (21 males and 7 females) were enrolled in the study of which twenty seven (27) subjects completed 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:
Of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator (s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or Is postmenopausal for at least 1 year; or Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
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 |