Evaluation of the Safety and Pharmacokinetics of MSI-195 to a Commercial S-Adenosylmethionine
Status:
Completed
Trial end date:
2013-06-08
Target enrollment:
Participant gender:
Summary
This study was a pharmacokinetic and safety evaluation of the S-adenosylmethionine
formulation MSI-195, and a commercial comparator. The study was broken into two stages. The
first stage was an exploratory single ascending dose design of MSI-195 in 8 healthy normal
male volunteers. The second stage was a single dose evaluation, targeting 26 male and female
volunteers at set doses of MSI-195 and commercial comparator in a cross-over design followed
by a food effect study on MSI-195. Plasma samples were collected and assayed for
S-adenosylmethionine. Pharmacokinetic parameters were calculated using that data.