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Phase 3 Study of Cysteamine Bitartrate Delayed-release (RP103) Compared to Cystagon® in Patients With Cystinosis

2014-11-25 06:48:36 | BioPortfolio

Published on BioPortfolio: 2014-11-25T06:48:36-0500

Clinical Trials [1068 Associated Clinical Trials listed on BioPortfolio]

Open-Label Safety & Superior Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Cystinosis

The purpose of this study is to gather information about the effectiveness (how well it works to treat cystinosis) and safety of a new form of cysteamine bitartrate called RP103, compared ...

Pilot Study of Safety, Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) of RP103 Compared to Cystagon® in Patients With Cystinosis

Cystinosis is an inheritable disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate) w...

Cysteamine Therapy for Major Depressive Disorder

The purpose of this study is to determine whether cysteamine bitartrate, an FDA-approved drug for a non-psychiatric condition, is safe and effective for the treatment of major depression.

Use of Cysteamine in the Treatment of Cystinosis

Cystinosis is an inherited disease resulting in poor growth and kidney failure. There is no known cure for cystinosis, although kidney transplantation may help the renal failure and prolo...

Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain

The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain.

PubMed Articles [5151 Associated PubMed Articles listed on BioPortfolio]

Long-term Physicochemical Stability of Concentrated Solutions of Noradrenaline Bitartrate in Polypropylene Syringes for Administration in the Intensive Care Unit.

Intensive care units use drug solutions within higher concentrations to avoid fluid overload. The purpose of this study was to evaluate the physicochemical stability of concentrated solutions of norad...

Thiol/disulfide status regulates the activity of thiol-containing kinases related to energy homeostasis in rat kidney.

Considering that thiol-containing enzymes like kinases are critical for several metabolic pathways and energy homeostasis, we investigated the effects of cystine dimethyl ester and/or cysteamine admin...

Cofactor Biogenesis in Cysteamine Dioxygenase: C-F Bond Cleavage with Genetically Incorporated Unnatural Tyrosine.

Cysteamine dioxygenase (ADO) is a thiol dioxygenase whose study has been stagnated by ambiguity as to whether or not it possesses an anticipated protein-derived cofactor. Herein, we report the discove...

Preparation of sustained release capsules by electrostatic dry powder coating, using traditional dip coating as reference.

Lately, a great deal of attention is being paid to capsule coating, since the coat protects active pharmaceutical ingredients (APIs) from damage, as is in the case of tablet and pellet. However, moist...

Mechanistic modelling of drug release from multi-layer capsules.

We propose a novel in silico model for computing drug release from multi-layer capsules. The diffusion problem in such heterogeneous layer-by-layer composite medium is described by a system of coupled...

Medical and Biotech [MESH] Definitions

A radiation-protective agent that oxidizes in air to form CYSTAMINE. It can be given intravenously or orally to treat radiation sickness. The bitartrate has been used for the oral treatment of nephropathic cystinosis.

Ethylamines, including CYSTEAMINE, that contain a sulfhydryl group in their structure.

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.

Dosage forms of a drug that act over a period of time by controlled-release processes or technology.

The lack of development of SEXUAL MATURATION in boys and girls at a chronological age that is 2.5 standard deviations above the mean age at onset of PUBERTY in a population. Delayed puberty can be classified by defects in the hypothalamic LHRH pulse generator, the PITUITARY GLAND, or the GONADS. These patients will undergo spontaneous but delayed puberty whereas patients with SEXUAL INFANTILISM will not.

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