British journal of clinical pharmacology
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Br J Clin Pharmacol · Jul 2005
Randomized Controlled Trial Clinical TrialClinical pharmacology of DP-b99 in healthy volunteers: first administration to humans.
To investigate the safety, tolerability and pharmacokinetics of DP-b99 in healthy volunteers. DP-b99 is a newly developed lipophilic, cell permeable derivative of BAPTA (1,2-bis(2-aminophenoxy)ethane-N,N,N',N'-tetraacetic acid), which selectively modulates the distribution of metal ions in hydrophobic milieu, and is in clinical development as a neuroprotectant for cerebral ischaemic stroke. To our knowledge no BAPTA derivative has ever been administered to man. Here we report the first human administration of DP-b99 in a phase I, two-part, double-blind, randomized placebo controlled study, with single IV doses of 0.003-1.0 mg kg(-1) day(-1) DP-b99 (part 1) or multiple ascending doses of 0.03-1.0 mg kg(-1) day(-1) DP-b99 over 4 days (part 2). ⋯ This study suggests that DP-b99 is well tolerated in healthy young and elderly volunteers within the dose range evaluated. Studies to investigate further the efficacy of the compound are in progress.
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Br J Clin Pharmacol · May 2005
Randomized Controlled Trial Comparative Study Clinical TrialVentilatory responses of healthy subjects to intravenous combinations of morphine and oxycodone under imposed hypercapnic and hypoxaemic conditions.
Previous isobolographic analysis revealed that coadministration of morphine and oxycodone produces synergistic antinociception in laboratory rodents. As both opioids can produce ventilatory depression, this study was designed to determine whether their ventilatory effects were synergistic when coadministered to healthy human subjects. ⋯ Although adverse ventilatory effects of these drugs were found as expected, no unexpected or disproportionate effects of any of the morphine and oxycodone treatments were found that might impede their use in combination for pain management.
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Br J Clin Pharmacol · Feb 2005
Randomized Controlled Trial Comparative Study Clinical TrialEfficacy and safety of three ophthalmic inserts for topical anaesthesia of the cornea. An exploratory comparative dose-ranging, double-blind, randomized trial in healthy volunteers.
Cataract surgery requires prolonged anaesthesia, concomitant with permanent hydration and lubrication of the cornea, in order to provide a clear view of the operation area. ⋯ Bupivacaine 1 mg seems to be the efficient and safe dose. The value of hyaluronic acid as a corneal hydration agent and used in association with bupivacaine will be the subject of further studies.
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Br J Clin Pharmacol · Feb 2005
Randomized Controlled Trial Comparative Study Clinical TrialEquivalent lung deposition of budesonide in vivo: a comparison of dry powder inhalers using a pharmacokinetic method.
The aim of this study was to compare lung deposition of budesonide administered from two dry powder inhalers, Giona Easyhaler 200 microg/dose and Pulmicort Turbuhaler 200 microg/dose by utilizing a pharmacokinetic method. ⋯ The results show that the lung deposition of budesonide from Giona Easyhaler 200 microg/dose and Pulmicort Turbuhaler 200 microg/dose dry powder inhalers is equivalent. The charcoal block used to prevent GI absorption of swallowed budesonide was found to be effective.
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Br J Clin Pharmacol · Dec 2004
Randomized Controlled Trial Multicenter Study Clinical TrialMedication reviews in the community: results of a randomized, controlled effectiveness trial.
To examine the effectiveness of a multidisciplinary service model delivering medication review to patients at risk of medication misadventure in the community. ⋯ Most studies emphasize efficacy and the best achievable clinical outcomes rather than whether an intervention will be effective in practice. The current trial showed that three of the four domains in the clinical value compass showed trends of improvement or were indeed improved in the relatively short follow-up period of the trial, suggesting that a service based on this model could achieve similar benefits in practice. A domiciliary medication review programme similar to this model has now been implemented into national Australian practice, where GPs and pharmacists are reimbursed by the Australian government for the provision of these services.