Study on Safety, Absorption and Metabolism of SYHA1402 Tablets in Healthy People

Summary

The trial used single-center, randomized, double-blind, placebo-controlled, single-dose study. The trial planned to enroll sixty-two healthy volunteers. The subjects were allocated to seven dose groups, including 25 mg (4+2), 50 mg (8+2), 100 mg (8+2), 200 mg (8+2), 400 mg (8+2), 800 mg (6+2) and 1200 mg (6+2). Each dose group was allocated test drugs and placebos according to the proportion of subjects in the brackets mentioned above.

Timeline

Start

2019-08-05

Primary completion

2020-01-14

Completion

2020-01-14

Publications

• Liang B, Wang J, Zhang G, Wang R, Cai Y. Safety, Tolerability and Pharmacokinetics of Single-Dose Oral SYHA1402 in Healthy Chinese Subjects. Neurol Ther. 2023 Jun;12(3):947-959. doi: 10.1007/s40120-023-00480-x. Epub 2023 Apr 24.

Drugs

Indications