{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["21(1)"],"submitter":["Cameron BR"],"pubmed_abstract":["<h4>Background</h4>A novel, high bioavailability oral, enteric coated tablet formulation of S-adenosylmethionine (MSI-195) has been developed for life science application. The present research reports on a Phase 1 study to (i) determine the safety of single doses of MSI-195 (ii) to determine the dose proportionality of MSI-195 at doses of 400, 800 and 1600 mg (iii) determine the pharmacokinetics of MSI-195 compared with a commercial reference product (SAM-e Complete™) over 24 h and (iv) to determine the effect of food on the pharmacokinetic profile of MSI-195 in human subjects.<h4>Methods</h4>This study was a pharmacokinetic and safety evaluation of MSI-195 and a commercial comparator broken into two stages. The first stage was an exploratory single ascending dose design of MSI-195 in 8 he"],"journal":["BMC pharmacology & toxicology"],"pagination":["88"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC7734772"],"repository":["biostudies-literature"],"pubmed_title":["Pharmacokinetic study of a novel oral formulation of S-adenosylmethionine (MSI-195) in healthy subjects: dose escalation, food effect and comparison to a commercial nutritional supplement product."],"pmcid":["PMC7734772"],"pubmed_authors":["Cameron BR","MacDonald ID","Ferreira L"],"additional_accession":[]},"is_claimable":false,"name":"Pharmacokinetic study of a novel oral formulation of S-adenosylmethionine (MSI-195) in healthy subjects: dose escalation, food effect and comparison to a commercial nutritional supplement product.","description":"<h4>Background</h4>A novel, high bioavailability oral, enteric coated tablet formulation of S-adenosylmethionine (MSI-195) has been developed for life science application. The present research reports on a Phase 1 study to (i) determine the safety of single doses of MSI-195 (ii) to determine the dose proportionality of MSI-195 at doses of 400, 800 and 1600 mg (iii) determine the pharmacokinetics of MSI-195 compared with a commercial reference product (SAM-e Complete™) over 24 h and (iv) to determine the effect of food on the pharmacokinetic profile of MSI-195 in human subjects.<h4>Methods</h4>This study was a pharmacokinetic and safety evaluation of MSI-195 and a commercial comparator broken into two stages. The first stage was an exploratory single ascending dose design of MSI-195 in 8 he","dates":{"release":"2020-01-01T00:00:00Z","publication":"2020 Dec","modification":"2025-04-04T12:49:16.934Z","creation":"2021-02-21T05:10:24Z"},"accession":"S-EPMC7734772","cross_references":{"pubmed":["33317621"],"doi":["10.1186/s40360-020-00466-7"]}}