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In the nucleus, the prednisolone–glucocorticoid receptor complex binds to specific DNA- binding sites known as glucocorticoid response elements (GREs) resulting in gene expression or inhibition. Luippold et al, who investigated the oral bioavailabilities in 13 participants using different formulations of 20 mg prednisolone tablets, reported that the time to reach maximum plasma prednisolone concentration (TSex acts as an influential factor in the pharmacokinetics and pharmacodynamics of drugs.The current study had some limitations. All the participants were informed of the experimental procedure with aims and risks and signed their written consent.Exclusion criteria included hypersensitivity to any steroid drug, requirement of chronic medication (eg, theophylline, antacid, glibenclamide, phenytoin, iron, or vitamins), abnormal gastrointestinal condition which may affect the absorption and distribution of prednisolone, donation of blood, or use of an investigational agent within 30 days preceding the first dose of the study.History and/or clinical evidence of significant cardiovascular, respiratory, hematological (including pancytopenia), neurological, dermatologic, gastrointestinal (including bleeding or ulcers), or hepatic disease were also considered as exclusion criteria.All participants were requested to abstain from taking any medication (including over-the-counter drugs) for at least 1 week prior to the study and until after it is completed. To avoid minor problems related to interindividual variation in pharmacokinetics of prednisolone, this study included healthy participants only.To the best of our knowledge, this is the first bioequivalence study of a generic prednisolone formulation conducted in healthy Bangladeshi volunteers. the site you are agreeing to our use of cookies. This site uses cookies. Participants were interviewed for any sort of physical or mental discomfort throughout the study period and also after 2 weeks of drug administration one of either formulation at the second period. A complete physical examination was also carried out before and 24 hours after drug administration. Listing a study does not mean it has been evaluated by the U.S. Federal Government. All the participants were advised to report any occurrence of adverse events at any time during the experiment.Median cubital vein was cannulated using a 20-G ×1.25-inch catheter (Vasofix Braunüle, B. Braun Melsungen AG, Melsungen, Germany), and heparinized normal saline injectable solution was flushed into the cannula to prevent blood clotting. the site you are agreeing to our use of cookies. Vital signs measurements, ECG recordings, and laboratory results were also found to be normal for all the participants.A summary of mean (SD) serum prednisolone pharmacokinetic parameters is listed in The statistical analysis results for all the pharmacokinetic parameters are presented in Aanalysis of variance was used to measure the effect of formulations, sequences, periods, sex, and subjects on pharmacokinetic parameters.The purpose of this study was to compare the bioavailability and tolerability of 2 formulations of prednisolone tablets in Bangladeshi healthy participants. Hopefully, this will reduce the health-care cost of the patients by allowing them to buy inexpensive generic prednisolone formulation instead of an expensive brand imported from foreign countries.The authors are thankful to all the volunteers, nurses, and physicians of Dhaka University Medical Center. Buccal cell collection swabChildren receiving glucocorticoids (Prednisone or Prednisolone or Methylprednisolone) are recruited in Immuno-hematological unit, dermatological unit , in pediatric nephrological unit or pediatric intensive care unitKeywords provided by Assistance Publique - Hôpitaux de Paris:Children Receiving Prednisone or Prednisolone or Methylprednisolone A comparison of plasma availabilityMolecular mechanisms of glucocorticoid action and selective glucocorticoid receptor agonistsPharmacokinetics of intravenous and oral prednisoloneThe binding of prednisolone in human serum and to recrystallized human albumin in vitroBioequivalence of different prednisolone tablet formulationsHuman liver microsomal steroid metabolism: identification of the major microsomal steroid hormone 6 beta-hydroxylase cytochrome P-450 enzymeSimultaneous analysis of prednisone, prednisolone and their major hydroxylated metabolites in urine by high-performance liquid chromatographyStudy on requirements of bioequivalence for registration of pharmaceutical products in USA, Europe and CanadaEthical principles for medical research involving human subjects. Approval of study protocol was given by the ethics committee of Bangladesh Medical Research Council (BMRC) with an ethics code of BMRC/ERC/2008/14-599. Members of _ can log in with their society credentials below Medical checks will be done during usual follow-up. 1 It is a potent synthetic glucocorticoid that is the active metabolite of its prodrug prednisone. According to the guidelines of US FDA, 2 drug formulations are considered bioequivalent when they are pharmaceutically equivalent as well as their bioavailability profiles are so similar that the possibility to produce clinically relevant differences (tolerability and efficacy) is very low.Prednisolone is rapidly available when taken orally. 1 It is a potent synthetic glucocorticoid that is the active metabolite of its prodrug prednisone. By continuing to browse For more information view the The aim of the study was to assess the pharmacokinetic and bioavailability of 2 formulations of 5-mg prednisolone tablets, reference product (Teva UK Limited) and Pred (Eskayef Bangladesh Ltd) as test product.

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