N-(2-Mercapto-2-methylpropionyl)-L-cysteine (SA96) の臨床第1相試験第1報;単回投与試験
1985 年 16 巻 3 号 p. 611-620
詳細
1985 年 16 巻 3 号 p. 611-620
A single dose Phase I study was performed on the newly developed antirheumatic, N (2-mercapto-2-methylpropionyl)-L-cysteine (SA 96)
Five healthy volunteers were administered 200 mg and 400 mg of SA 96 in a singledose after breakfast, after which the safety and pharmacokinetics of the drug were studied with the following results.
1) No remarkable subjective complaints were registered except for belching.
1) No significant anomaly was noted in clinical signs or laboratory examination values.
3) The average concentration of SA 96 in the blood reached highest concentration by about 1 hour after administration and repidly disappeared thereafter . About 40% of the SA96 was excreted into the urine in 24 hours.
Based on the above results, we plan to proceed to a multiple dose study in order to further evaluate the safety of SA96.
