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Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

2014-08-27 03:32:56 | BioPortfolio

Summary

The objective of this study was to assess the bioequivalence of a potential generic 600 mg oxcarbazepine tablet formulation with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, folloiwng a single 600 mg dose administered with food.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Epilepsy

Intervention

Oxcarbazepine

Location

MDS Pharma Services
Montreal
Quebec
Canada
H4R 2N6

Status

Completed

Source

Roxane Laboratories

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:32:56-0400

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Medical and Biotech [MESH] Definitions

A disorder characterized by the onset of myoclonus in adolescence, a marked increase in the incidence of absence seizures (see EPILEPSY, ABSENCE), and generalized major motor seizures (see EPILEPSY, TONIC-CLONIC). The myoclonic episodes tend to occur shortly after awakening. Seizures tend to be aggravated by sleep deprivation and alcohol consumption. Hereditary and sporadic forms have been identified. (From Adams et al., Principles of Neurology, 6th ed, p323)

A disorder characterized by recurrent episodes of paroxysmal brain dysfunction due to a sudden, disorderly, and excessive neuronal discharge. Epilepsy classification systems are generally based upon: (1) clinical features of the seizure episodes (e.g., motor seizure), (2) etiology (e.g., post-traumatic), (3) anatomic site of seizure origin (e.g., frontal lobe seizure), (4) tendency to spread to other structures in the brain, and (5) temporal patterns (e.g., nocturnal epilepsy). (From Adams et al., Principles of Neurology, 6th ed, p313)

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A subtype of epilepsy characterized by seizures that are consistently provoked by a certain specific stimulus. Auditory, visual, and somatosensory stimuli as well as the acts of writing, reading, eating, and decision making are examples of events or activities that may induce seizure activity in affected individuals. (From Neurol Clin 1994 Feb;12(1):57-8)

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