Fed Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg
Summary
The objective of this study was to investigate the bioequivalence of Mylan's zonisamide, 100 mg capsules to Elan's Zonegran® 100 mg capsules following a single, oral 100 mg (1 x 100 mg) dose administered under fed conditions.
Study Design
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label
Conditions
Healthy
Intervention
Zonisamide Capsules 100 mg, Zonegran® Capsules 100 mg
Location
Kendle International Inc.
Morgantown
West Virginia
United States
26505
Status
Completed
Source
Mylan Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00649714
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Bacterial Capsules
An envelope of loose gel surrounding a bacterial cell which is associated with the virulence of pathogenic bacteria. Some capsules have a well-defined border, whereas others form a slime layer that trails off into the medium. Most capsules consist of relatively simple polysaccharides but there are some bacteria whose capsules are made of polypeptides.
Capsules
Hard or soft soluble containers used for the oral administration of medicine.
Golgi-mazzoni Corpuscles
Thin capsules enveloping end nerve fibrils in the subcutaneous tissue of fingers.
Bryopsida
A class of plants within the Bryophyta comprising the mosses, which are found in both damp (including freshwater) and drier situations. Mosses possess erect or prostrate leafless stems, which give rise to leafless stalks bearing capsules. Spores formed in the capsules are released and grow to produce new plants. (Concise Dictionary of Biology, 1990). Many small plants bearing the name moss are in fact not mosses. The "moss" found on the north side of trees is actually a green alga (ALGAE, GREEN). Irish moss is really a red alga (ALGAE, RED). Beard lichen (beard moss), Iceland moss, oak moss, and reindeer moss are actually LICHENS. Spanish moss is a common name for both LICHENS and an air plant (TILLANDSIA usneoides) of the pineapple family. Club moss is an evergreen herb of the family LYCOPODIACEAE.
Primulaceae
A plant family of the order Primulales, subclass Dilleniidae, class Magnoliopsida. The flowers have both stamens and pistil, and the fruits are capsules.
Clinical Trials
Fasting Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg
The objective of this study was to investigate the bioequivalence of Mylan's zonisamide, 100 mg capsules to Elan's Zonegran® 100 mg capsules following a single, oral 100 mg (1 x 100 mg) d...
Fed Bioavailability Study of Zonisamide Capsules
The purpose of this study is to evaluate the relative bioavailability (rate and extent of absorption) of a test formulation of zonisamide capsules compared to the reference formulation, Zo...
Fasting Bioavailability Study of Zonisamide Capsules
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of zonisamide capsules to an equivalent dose of a reference formulation, Zonegran®...
The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Zonisamide 100 mg Capsule to that of Zonegran® 100 mg Capsule after a single, one-capsule dose...
Fed Study of Anagrelide Hydrochloride Capsules 1 mg to Agrylin® Capsules 1 mg
The objective of this study was to investigate the bioequivalence of Mylan's anagrelide HCl 1 mg capsules to Shire US's Agrylin® 1 mg capsules following a single, oral 1 mg (1 x 1 mg) dos...
PubMed Articles
Highly fluorescent M(2)L(4) molecular capsules with anthracene shells.
M(2)L(4) molecular capsules self-assembled from M(ii) ions (where M = Zn, Ni, and Pd) and bent bidentate ligands constructed from anthracene fluorophores. The Ni(ii) and Zn(ii) capsules exhibited weak...
Modular click assembly of degradable capsules using polyrotaxanes.
A modular approach for the formation of degradable capsules using polyrotaxanes (PRXs) is described. The PRXs consist of α-cyclodextrin (αCD) and poly(ethylene glycol) (PEG), which are both biologic...
Synthesis and characterization of ratiometric ion-sensitive polyelectrolyte capsules.
Micrometer-sized polyelectrolyte capsules are synthesized, which have ion-sensitive fluorophores embedded in their cavities. As the membranes of the capsules are permeable to ions, the fluorescence of...
Assembly-driven synthesis of hybrid molecular capsules controlled by chiral sorting.
Chiral capsules with polar interiors (reversed capsules) undergo heterochiral sorting and exhibit positive mutalism - both hemispheres mutually benefit from the association. This feature can be couple...
Release me: Polyelectrolyte capsules with different cargo in their cavities and plasmonic and magnetic nanoparticles in their walls were synthesized. Enzymatic reactions were triggered inside cells by...
