A Single-dose Study to Investigate the Tolerance and Pharmacokinetics of Finamine Tablets in China

Summary

Design：Randomization, double-blind, single-center, single-dose, dose-escalation , placebo and parallel control Objectives： 1. To investigate the tolerability and safety of Chinese healthy adult subjects after a single oral administration of Finamine tablets; 2. To investigate the pharmacokinetic (PK) characteristics of Finamine tablets; 3. To provide dose setting basis for follow-up clinical studies. Investigational subject:Healthy-adult subjects in China 34 cases (including 4 cases of the pre- trial), of which the 150mg dose group is in the 4 cases of pre- trial (open, all accepted Finamine tablets orally, among whom, two receive it under fasting condition , and the other two receive it half an hour post a high-fat meal started). There are 6 cases in the formal trial (the subjects' ratio of investigational drug to placebo is 2:1). In all other dose groups, the subjects' ratio of investigational drug to placebo is 3:1.

Timeline

Start

2017-08-15

Primary completion

2018-04-27

Completion

2018-04-27

Drugs

Indications