Clinical therapeutics
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Clinical therapeutics · Apr 2009
Randomized Controlled Trial Comparative StudyPretreatment with flurbiprofen axetil, flurbiprofen axetil preceded by venous occlusion, and a mixture of flurbiprofen axetil and propofol in reducing pain on injection of propofol in adult Japanese surgical patients: a prospective, randomized, double-blind, placebo-controlled study.
Pain on injection of propofol is a common clinical problem. Flurbiprofen axetil, an injectable prodrug of flurbiprofen, with or without venous occlusion has been reported to reduce this pain. A search of the existing literature did not identify comparative studies of 3 different techniques, including pretreatment with flurbiprofen axetil, flurbiprofen axetil preceded by venous occlusion, and mixture of propofol and flurbiprofen axetil, for reducing pain on injection of propofol. ⋯ In this study of adult Japanese surgical patients, pretreatment with flurbiprofen axetil 50 mg preceded by venous occlusion was found to be more effective in reducing pain on injection of propofol than the other flurbiprofen axetil administration strategies tested.
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Clinical therapeutics · Apr 2009
Randomized Controlled Trial Comparative StudyPharmacokinetics and bioequivalence evaluation of two formulations of 10-mg amlodipine besylate: an open-label, single-dose, randomized, two-way crossover study in healthy Chinese male volunteers.
Amlodipine is a third-generation dihydropyridine calcium antagonist for the treatment of angina and hypertension. The relative bioavailability of a newly developed dispersible tablet as compared with an established branded formulation has not been reported in a Chinese population. ⋯ In this small study in healthy Chinese adult male volunteers, a single 10-mg dose of the dispersible tablet formulation (test) of amlodipine besylate met the regulatory criteria for bioequivalence to the established tablet formulation (reference) based on the rate and extent of absorption. Both formulations were well tolerated.
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Clinical therapeutics · Apr 2009
Randomized Controlled Trial Comparative StudyPharmacokinetic properties and bioequivalence of two formulations of arbidol: an open-label, single-dose, randomized-sequence, two-period crossover study in healthy Chinese male volunteers.
Arbidol is an antiviral drug indicated for the prevention and treatment of all types of influenza infection and some other kinds of acute respiratory infections, specifically against influenza groups A and B, and severe acute respiratory syndrome. It is used to help prevent influenza infection as long as necessary with little risk for influenza mutation rendering it less effective. ⋯ In this study in healthy Chinese male volunteers, the dispersible tablet formulation and the 200-mg capsule formulation of arbidol met the SFDA's regulatory definition of bioequivalence based on the rate and extent of absorption.
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Clinical therapeutics · Apr 2009
Multicenter StudyTwo first-in-human, open-label, phase I dose-escalation safety trials of MEDI-528, a monoclonal antibody against interleukin-9, in healthy adult volunteers.
Interleukin-9 (IL-9) is involved in pathogenic aspects of the asthmatic response, including induction of the proliferation of T-helper type 2 lymphocytes, mucus production, and mast-cell differentiation, proliferation, and recruitment to the lung. In preclinical studies in mice, inhibition of IL-9 through neutralizing monoclonal antibody (mAb) treatment partially reduced airway hyperresponsiveness and mast-cell progenitor migration to the lung. ⋯ Administered intravenously or subcutaneously, MEDI-528 had an acceptable safety profile and exhibited linear pharmacokinetics over the dose range studied in healthy adults in these Phase I studies. The findings support further investigation of MEDI-528 in multiple-dose trials in patients with asthma. ClinicalTrials.gov Identification numbers: NCT00192296 (intravenous study); NCT00116168 (subcutaneous study).
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Clinical therapeutics · Apr 2009
Randomized Controlled Trial Comparative StudyA randomized, controlled study comparing a lidocaine patch, a placebo patch, and anesthetic injection for treatment of trigger points in patients with myofascial pain syndrome: evaluation of pain and somatic pain thresholds.
Myofascial pain syndrome (MPS), a regional pain condition caused by trigger points in muscle or muscle fascia, produces muscle pain, tenderness, and disability. The gold standard of treatment for MPS-infiltration of trigger points with anesthetic-may provoke discomfort to the patients and require medical intervention. ⋯ Lidocaine patches were effective in, and highly acceptable to, these patients with MPS and high tissue hypersensitivity.