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Justificative: This trial was conducted in order to register a new generic product of Rivaroxaban. Objective: To evaluate the bioequivalence of rivaroxaban formulations manufactured by Eurofarma Laboratórios S/A and the reference drug, Xarelto (Bayer) under fasting and fed conditions. Methods: Three randomized, open label, balanced, 2 treatments, 4 periods, 2 sequences, single dose, full replicate, crossover studies in 48 healthy adult human subjects under fed and fasting conditions for rivaroxaban 10 mg and 20 mg. Rivaroxaban concentrations in plasma were determined using a validated HPLC-MS/MS method.

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Objective: The purpose of this study was to compare the bioavalability between the two 80 mg Valsartan Tablets formulations and to evaluate the bioequivalence of Reference and Test formulations of Valsartan Tablets 80 mg in Healthy adult chinese Male and Female subjects under Fasting and Fed condition.

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Objective: This study was conducted to investigate the effects of gabapentin enacarbil (GEn) on sleep EEG, heart rate (HR), blood presssure, anterior tibialis EMG activity (PLMs power) and subjective complaints in subjects with moderate to severe RLS and disturbed sleep. Methods: This was a single site, single-blind, placebo run-in, fixed dose single group polysomnography (PSG) study. Eligible subjects (age 24-66 years) were treated with placebo for one week and GEn (600 mg/day) for 4 weeks. Two in-laboratory PSGs were collected for adaptation and baseline at the end of the placebo run-in period and for re-adaptation and efficacy assessment at the end of the 4-week treatment period. The primary endpoint was the difference in PSG derived cortical arousal intensity (arousal scale, 0-9) associated with PLMs between 4 weeks of treatment with GEn and placebo. Secondary endpoints included changes in HR responses (ΔHR), nocturnal systolic blood pressure (SBP) changes (>10 mmHg) secondary to PLMs and PLMs power. Other PSG and subjective measures were assessed. Results: Of 20 subjects enrolled, 18 completed the study. Subjects treated with GEn did not show significant improvements in cortical arousal intensity and ΔHR. However, subjects showed reduced PLMs power (p= 0.013) and associated reductions in nocturnal SBP per hour of sleep (p= 0.041) GEn showed significant improvement in other PSG parameters and subjective endpoints. Conclusion: The data suggests that GEn reduces the frequency and power of PLMs and the corresponding SBP changes in subjects with RLS. Despite reducing the total number of PLM associated arousals and nocturnal HR, the study did not demonstrate consistent effects of GEn on cortical arousal intensity and corresponding HR changes associated with PLMs. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT02424695

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Donepezil is a potent, selective, noncompetitive and reversible inhibitor of acetylcholinesterase, commonly used for the treatment of Alzheimer’s disease. The form of orally disintegrating tablets (ODTs) is a good alternative dosage form for patients who have a difficulty in swallowing conventional tablets or capsules.

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WLAN (wireless local area network) is used as an important worldwide communication-technique. By this, always there is an electromagnetic field exposure. In contrast to the ICNIRP-safety guidelines, whereby no bioeffect is possible by these low-energetic electromagnetic fields, we found artificial signals in the nervous system in dependence on WLAN- exposure.

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Pantoprazole is a H+,K+-ATPase enzyme inhibitor for the treatment of acid-related gastrointestinal diseases. The Government Pharmaceutical Organization (GPO), Thailand had developed Pantoprazole GPO® (pantoprazole 40 mg delayed-release tablets) as a generic substitute for the corresponding innovator product, CONTROLOC® 40 mg.

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Previous studies reported that the paraspinal muscles of adolescents with severe idiopathic scoliosis scheduled for surgery contain higher proportion of type Ⅰ fibers on the convex side. However, the muscle properties are unknown in mild adolescent idiopathic scoliosis. The objective of this study was to evaluate the differences among the convex, concave and control sides of the paraspinal muscles in patients with mild AIS and healthy individuals and to help in the treatment of mild AIS patients.

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Fixed-dose combination tablet formulation of efavirenz/emtricitabine/tenofovir disoproxil fumarate 600/200/300 mg is an antiretroviral therapy comprising one non-nucleoside reverse-transcriptase inhibitor and two nucleoside reverse-transcriptase inhibitors to control human immunodeficiency virus infection.

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Tepilamide fumarate (PPC-06) is a new, patented prodrug of monomethyl fumarate (MMF), belonging to the fumaric acid esters (FAEs) class of drugs. The efficacy and safety of a 400 mg PPC-06 dose administered twice daily, achieved thus far through concomitant intake of two tablets of 200 mg, was demonstrated previously in two Phase 2 clinical trials on patients with moderate to severe chronic plaque-type psoriasis.

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A comparative randomized, single dose, two-way crossover, open label study was carried out to assess bioequivalence and tolerability of test (ZOLAN GPO®) and reference (Zyprexa Zydis®) products of olanzapine 5 mg orally disintegrating tablets for interchange ability in the same quality and safety.

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Migraine is a global disorder and considerably affecting people`s quality of life. Treatments include nonsteroidal anti-inflammatory drugs-containing medicinal products among whom acetylsalicylic acid-containing Aspirin® has been proven effectively to relief migraine headache. Early treatment is recommended for patients with migraine attacks.

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The indigenous Amerindian populations living in the southern interior part of Suriname have to date largely maintained their traditional hunter-gatherer life-style. In this study we compared the prevalence of metabolic syndrome (MeTS) and its component risk factors between indigenous Amerindian women of the interior of Suriname, with indigenous Amerindian women living in the coastal-rural areas who have a more urbanized lifestyle. We focused on women since the Suriname Health study showed that Indigenous women had the second highest MeTS prevalence nationwide.

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Myasthenia gravis is an autoimmune disease characterized by motor plaque dysfunction due to antibodies against post-synaptic membrane proteins. Myasthenic symptoms classically wax and wane and are more intense at the end of the day, although they may be constant in severe pictures. Almost every patient have eyelid ptosis and double vision, and the majority of them also have proximal muscle weakness. Reversible cholinesterase inhibitors are the first-line treatment, but patients who do not achieve symptom control should receive immunosuppressive therapy, whose options include azathioprine, cyclosporine, mycophenolate, intravenous immunoglobulin and thymectomy, with different profiles of efficacy, safety and tolerability.

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In Mexico, the immediate-release formulation of omeprazole 20 mg in combination with 1100 mg of sodium bicarbonate (oral capsules) is indicated for patients over 18 years for the treatment of gastritis, reflux, heartburn and the sensation of emptiness caused by the excessive acid production.

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Sphincter of Oddi dysfunction (SOD) is a known gastrointestinal disorder that has been well documented but is difficult to diagnose noninvasively.

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