Bioavailability Study of Clonazepam ODT Under Fasting Conditions
To compare the single-dose bioavailability of Clonazepam ODT 1 mg and Klonopin Wafers 1 mg ODT
To compare the single -dose bioavailability of kali's Clonazepam ODT 1 mg with that of Klonopin Wafers 1 mg ODT by Roche pharmaceuticals following a single oral dose under fasting conditions.
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
To Determine Bioequivalence Under Fasting Conditions
Clonazepam, Klonopin Wafers
Par Pharmaceutical, Inc.
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00652912
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
A test to determine the ability of an individual to maintain HOMEOSTASIS of BLOOD GLUCOSE. It includes measuring blood glucose levels in a fasting state, and at prescribed intervals before and after oral glucose intake (75 or 100 g) or intravenous infusion (0.5 g/kg).
An autosomal recessive fructose metabolism disorder due to absent or deficient fructose-1,6-diphosphatase activity. Gluconeogenesis is impaired, resulting in accumulation of gluconeogenic precursors (e.g., amino acids, lactate, ketones) and manifested as hypoglycemia, ketosis, and lactic acidosis. Episodes in the newborn infant are often lethal. Later episodes are often brought on by fasting and febrile infections. As patients age through early childhood, tolerance to fasting improves and development becomes normal.
Abstaining from all food.
An anticonvulsant used for several types of seizures, including myotonic or atonic seizures, photosensitive epilepsy, and absence seizures, although tolerance may develop. It is seldom effective in generalized tonic-clonic or partial seizures. The mechanism of action appears to involve the enhancement of GAMMA-AMINOBUTYRIC ACID receptor responses.
Measurement or recording of contraction activity of the uterine muscle. It is used to determine progress of LABOR, OBSTETRIC and assess status of pregnancy. It is also used in conjunction with FETAL MONITORING to determine fetal response to stress of maternal uterine contractions.
To compare the single-dose bioavailability of Clonazepam tablets 1 mg and Klonopin tablets 1 mg
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