Bioavailability Study of Clonazepam ODT Under Fasting Conditions

2014-07-24 09:18:10 | BioPortfolio


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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label


To Determine Bioequivalence Under Fasting Conditions


Clonazepam, Klonopin Wafers




Par Pharmaceutical, Inc.

Results (where available)

View Results


Published on BioPortfolio: 2014-07-24T09:18:10-0400

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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.

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