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The objective of this study was to compare the relative bioavailability of the test formulation of Ropinirole (TEVA Pharmaceuticals USA) with already marketed reference of Requip® (Manufactured by SmithKline Beecham Pharmaceuticals for GlaxoSmithKline) under fasting conditions in healthy, non-smoking, adult subjects.
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Ropinirole HCl 0.25 mg Tablets, Requip® 0.25 mg Tablets
Novum Pharmaceutical Research Services
Teva Pharmaceuticals USA
Published on BioPortfolio: 2014-08-27T03:24:51-0400
The purpose of this study is to compare relative bioavailability of the test formulation of ropinirole hydrochloride 0.25 mg tablets (Manufactured and distributed by TEVA Pharmaceuticals U...
The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole tablets,0.25 mg, to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fed conditions using a s...
To investigate the efficacy and the safety of ropinirole PR/XR tablets to ropinirole immediate release (IR) tablets with advanced Parkinson's disease in conjunction with L-dopa in a double...
REQUIP was granted approval for the treatment of Parkinson's Disease on 20 October 2006. REQUIP is expected to be used for a long term in clinical practice. However, no long-term clinical...
This study is a Phase III, multicentre, randomized, initial double-blind study with subsequent open label phases. The study will havea screening phase (4 weeks), a dose increase effect ver...
The subdivision behavior of polymeric tablets produced with the well-known polymers Soluplus (SOL), polyvinyl pyrrolidone co-vinyl acetate (PVPVA) and hydroxypropyl methylcellulose (HPMC) was evaluate...
Ethanol-treated starch (ETS) shows potentiality to be used for binder of pharmaceutical tablets. This study was aimed to evaluate the mechanical strength, structural and hydration properties of ETS ta...
Tablets can be manipulated in several ways to obtain a fraction as the dose - a practice frequently seen in paediatric care due to lack of suitable formulations. Splitting tablets, prior to fragment d...
Orally disintegrating tablets (ODTs) produced by lyophilisation have a unique porous structure which leads to a favorable orodispersable functionality. They possess ultra-fast disintegration kinetics,...
Mini-tablets are an age appropriate dosage form for oral administration to pediatric and geriatric patients, either as individual mini-tablets or as composite dosage units. Smaller mini-tablets than t...
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
A disaccharide of GLUCOSE and GALACTOSE in human and cow milk. It is used in pharmacy for tablets, in medicine as a nutrient, and in industry.
A method of treating an ALLERGY by administering ALLERGENS, in liquid formulation or tablets, to the ORAL MUCOSA under the tongue.
Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed)
Usually inert substances added to a prescription in order to provide suitable consistency to the dosage form. These include binders, matrix, base or diluent in pills, tablets, creams, salves, etc.
The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...