NCT04162275

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

A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Tolerance and Pharmacokinetics Study of Oral Taking Finamine Tablets in Chinese Healthy-adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Yiling Pharmaceutical Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Finamine tablets	taken Finamine tablets orally
DRUG	Placebo tablets	taken Placebo tablets orally

Timeline

• Start date: 2017-08-15
• Primary completion: 2018-04-27
• Completion: 2018-04-27
• First posted: 2019-11-14
• Last updated: 2021-12-14

Locations

1 site across 1 country: China