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This is a randomized, two-way crossover, multicenter study evaluating the consumer preference of Phenylephrine Extended Release Tablets, 30 mg to be taken as one tablet every 12 hours, or phenylephrine tablets, 10 mg to be taken as one tablet every 4 hours in subjects with at least mild allergic rhinitis and nasal congestion. Approximately 250 subjects will complete a questionnaire after taking one test product for 3 days followed by a 3 day (± 1 day) washout period; and then taking the alternate test product for 3 days. Analysis of which product the consumer preferred, if any, and which product was more convenient, if any, will be evaluated.
Allocation: Randomized, Control: Active Control, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Phenylephrine Hydrochloride Extended Release Tablets 30 mg, Phenylephrine Hydrochloride Tablets, 10 mg
Published on BioPortfolio: 2014-07-23T21:13:21-0400
This study will assess the food-effect bioavailability of an extended release formulation of phenylephrine HCl and its bioequivalence to the marketed immediate release phenylephrine HCl pr...
Randomized, placebo-controlled double-blind, crossover design study; 116 subjects randomized on Day 1 to obtain 98 completed subjects. Study will be composed of a 7-day period of therapy w...
The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone hydrochloride extended-release tablets (Sandoz) with Opana extended release oxymorphone hydrochloride...
The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone hydrochloride extended release tablets (Sandoz) with Opana extended release oxymorphone hydrochloride...
This study will evaluate the safety of phenylephrine hydrochloride 10 mg + acetaminophen 500 mg + dimethindene maleate 1 mg compared to phenylephrine hydrocloride 10 mg alone in healthy vo...
A randomized, double-blind, non-inferiority study of hydromorphone hydrochloride immediate-release tablets versus oxycodone hydrochloride immediate-release powder for cancer pain: efficacy and safety in Japanese cancer patients.
Hydromorphone is a standard opioid analgesic for cancer pain that, prior to this study, was not approved in Japan, where options for opioid switching are limited. We aimed to investigate the efficacy ...
3D-printed tablets are a promising new approach for personalized medicine. In this study, we fabricated composite tablets consisting of two components, a drug and a filler, by using a fused deposition...
Phenylephrine is an α1 adrenergic receptor agonist that causes pulmonary vasoconstriction, and so may effectively enhance hypoxic pulmonary vasoconstriction (HPV). However, there is little evidence t...
Vardenafil hydrochloride (VAR) is an erectile dysfunction treating drug. VAR has a short elimination half-life (4-5 h) and suffers low oral bioavailability (15%). This work aimed to explore the dual...
Dissolution speeds of tablets printed via Fused Deposition Modeling (FDM) so far are significantly lower compared to powder or granule pressed immediate release tablets. The aim of this work was to pr...
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
A pharmaceutical preparation of sitagliptin phosphate and metformin hydrochloride that is used in the treatment of TYPE 2 DIABETES.
An alpha-adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent.
Sympathetic alpha-adrenergic agonist with actions like PHENYLEPHRINE. It is used as a vasoconstrictor in circulatory failure, asthma, nasal congestion, and glaucoma.
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.
The term allergy is used to describe a response, within the body, to a substance, which is not necessarily harmful in itself, but results in an immune response and a reaction that causes symptoms and disease in a predisposed person, which in turn can cau...