A Bioavailability Study of Naproxen Sodium and Diphenhydramine Hydrochloride Under Fasting Conditions and Naproxen Sodium and Diphenhydramine Hydrochloride Combination Under Fasting and Fed Conditions

The purpose of the current trial is to evaluate the bioavailability of a single oral dose of naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or DPH HCL (2 Allergy Relief x 25 mg tablets) under fasting conditions.

开始日期2012-01-01

申办/合作机构

Bayer AG

100 项与萘普生钠/盐酸苯海拉明相关的临床结果

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100 项与萘普生钠/盐酸苯海拉明相关的转化医学

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100 项与萘普生钠/盐酸苯海拉明相关的专利（医药）

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项与萘普生钠/盐酸苯海拉明相关的文献（医药）

2013-09-01·Therapeutic advances in neurological disorders2区 · 医学

Sumatriptan/naproxen sodium combination versus its components administered concomitantly for the acute treatment of migraine: a pragmatic, crossover, open-label outcomes study

2区 · 医学

ArticleOA

作者: Reuss, Gena ; Landy, Stephen ; Hoagland, Dakota ; Saiers, Jane ; Hoagland, Rebecca

Objective::

Efficacy and tolerability profiles of Treximet [sumatriptan/naproxen sodium combination tablet (SNC)] have been established in clinical trials but have to date been virtually unstudied in pragmatic research. The primary objective of this study was to compare the overall satisfaction of SNC to its monotherapy components, S/N [one 100 mg Imitrex tablet (S) and two Aleve (naproxen sodium) 220 mg tablets, total dose 440 mg (N)] administered concomitantly using the Patient Perception of Migraine Questionnaire –Revised (PPMQ-R).

Methods::

Adults with migraine ( n = 50) without ‘medication overuse headache’ were treated for up to 18 migraine attacks per 3-month study period with study medication; SNC during one study period and S/N during the other study period. For all endpoints, differences between treatments were compared with paired t tests.

Results::

The percentage of patients reporting satisfied/very satisfied for Overall Satisfaction of SNC versus S/N (primary endpoint) was 85% versus 72% respectively ( p = 0.054). For Overall Effectiveness, the results were 82% for SNC versus 73% for S/N ( p = 0.159); and for Overall Side Effects the results were 86% for SNC versus 69% for S/N ( p = 0.005). Mean PPMQ-R scores reflect greater satisfaction with SNC than S/N for Total score and for each of four subscales. The difference between SNC and S/N was significant for the Ease of Use subscale ( p = 0.004) and met the criterion of being clinically meaningful for both the Total score and Ease of Use. SNC did not differ from S/N with respect to pain-free response 2 h post dose, pain relief 2 h post dose, sustained 24 h pain-free response, or sustained 24 h pain relief.

Conclusion::

Although the primary endpoint only just failed, the results of this pragmatic outcomes study demonstrate SNC to have benefits over its concomitantly administered components in the acute treatment of migraine.

2012-08-01·Journal of pharmaceutical sciences3区 · 医学

Sodium-23 Ssolid-Sstate Snuclear Smagnetic Sresonance of Scommercial Ssodium Snaproxen and its Ssolvates

3区 · 医学

Article

作者: Ilia Korobkov ; Kevin M.N. Burgess ; David L. Bryce ; Aurore Lebrun ; Elisabeth Messner-Henning ; Frédéric A. Perras

We report on the investigation of sodium coordination environments with solid-state ²³Na nuclear magnetic resonance (NMR) spectroscopy of various hydrates and solvates of sodium naproxen (SN), a commercially available anti-inflammatory drug sold over the counter as Aleve®, among other names. The ²³Na quadrupolar coupling constant is found to change significantly depending on the hydration state, and subtle changes in oxygen coordination environment about the sodium cations were apparent in the NMR spectra. High-resolution double-rotation NMR experiments are also performed on powdered samples to obtain solution-like ²³Na NMR spectra. Our attempts at crystallizing various solvates of SN have led to the characterization of the first crystal structure for the heminonahydrated form. The composition of commercial SN is also investigated and it is shown that Aleve® is composed of approximately 80% monohydrate solvate. Density-functional theory calculations, using the gauge-including projector-augmented-wave formalism, allow for the assignment of ²³Na NMR peaks to specific sodium sites in the reported X-ray crystal structure.

2012-02-01·Emergency medicine journal : EMJ3区 · 医学

Short answer question case series: diagnosis and management of glaucoma

3区 · 医学

Article

作者: Beck, Josh ; Jang, Timothy B

A 40-year-old woman with history of hypertension and migraines presents with a complaint of headache. Two days prior to presentation she began to experience a left-sided, throbbing headache that radiated to the right and was accompanied by blurring of left eye vision and nausea. The blurred vision and headache were exacerbated by bright light, consistent with prior migraine attacks. She took her usual dose of naproxen with resolution of her nausea but still had a mild headache and blurred left eye vision. Two hours prior to presentation she walked outside and experienced worsening of her headache upon exposure to the sunlight, but without concomitant change in her vision or nausea. Aleve did not improve her symptoms, so she decided to present to the emergency department. Her vital signs were normal. 1. Which features are consistent with migraine in this patient? 2. What other important aetiologies of headache should be considered in this patient? …

100 项与萘普生钠/盐酸苯海拉明相关的药物交易

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