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Sponsored by: |
Ranbaxy Laboratories Limited |
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Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00778271 |
The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Parke-Davis (Neurontin®) 400 mg Gabapentin, following administration of a 400 mg dose under fasting conditions
Condition | Intervention |
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Healthy |
Drug: Gabapentin 400mg capsules |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Ranbaxy and Park:-Davis (Neurontin®) 400 mg Gabapentin Capsules in Healthy Adult Volunteers Under Fasting Conditions |
Enrollment: | 26 |
Study Start Date: | September 2002 |
Study Completion Date: | December 2002 |
Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Gabapentin 400mg capsules
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Drug: Gabapentin 400mg capsules |
2: Active Comparator
Neurontin® 400 mg capsules
|
Drug: Gabapentin 400mg capsules |
This was an open-label, randomized, single-dose, 2-way crossover relative bioavailability study performed on 24 healthy adult volunteers and 2 alternates. A total of 26 subjects (22 males and 4 females) completed the clinical phase of the study. In each period, subjects were housed from at least 10 hours before dosing until after the 36-hour blood draw. Both periods were separated by a wash out period of 7 days A total of 26 healthy adult volunteers (22 males and 4 non-pregnant females) enrolled in and completed the clinical phase of the study enrolled in and completed the clinical phase of the study
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods:
Other birth control methods may be deemed acceptable. Postmenopausal women with amenorrhea for at least 2 years will be eligible.
Exclusion Criteria:
Subject candidates must not be enrolled in the study if they meet any of the following criteria:
In addition, history or presence of:
Subjects who, through completion of the study, would have donated in excess of:
Responsible Party: | Ranbaxy Research labs ( Dr. tausif Monif ) |
Study ID Numbers: | AA01819 |
Study First Received: | October 22, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00778271 History of Changes |
Health Authority: | Canada: Health Canada |
Bioequivalence gabapentin 400mg capsules fasting conditions |
Excitatory Amino Acids Neurotransmitter Agents Tranquilizing Agents Gabapentin Psychotropic Drugs Calcium Channel Blockers Central Nervous System Depressants Healthy |
Cardiovascular Agents Antimanic Agents Calcium, Dietary Gamma-Aminobutyric Acid Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Anticonvulsants |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Gabapentin Physiological Effects of Drugs Psychotropic Drugs Calcium Channel Blockers Antiparkinson Agents Excitatory Amino Acid Agents Membrane Transport Modulators Sensory System Agents Therapeutic Uses Gamma-Aminobutyric Acid |
Analgesics Excitatory Amino Acid Antagonists Tranquilizing Agents Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Pharmacologic Actions GABA Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |