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Sponsored by: |
Ranbaxy Laboratories Limited |
---|---|
Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00778232 |
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.
Condition | Intervention |
---|---|
Healthy |
Drug: Gabapentin tablets 800 mg |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Relative Bioavailability Study of 800 mg Gabapentin Tablets Under Non-Fasting Conditions |
Enrollment: | 22 |
Study Start Date: | October 2002 |
Study Completion Date: | November 2002 |
Primary Completion Date: | November 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited
|
Drug: Gabapentin tablets 800 mg |
2: Active Comparator
Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd
|
Drug: Gabapentin tablets 800 mg |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Ranbaxy Research Labs ( Dr. Tausif Monif ) |
Study ID Numbers: | R01-826 |
Study First Received: | October 22, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00778232 |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Gabapentin tablets 800 mg fed conditions |
Excitatory Amino Acids Calcium, Dietary Malnutrition Gabapentin Healthy |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Cardiovascular Agents |
Antimanic Agents Pharmacologic Actions Membrane Transport Modulators Sensory System Agents Therapeutic Uses Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants Excitatory Amino Acid Antagonists |