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

NCT04162275 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-12-14

No results posted yet for this study

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

DRUG

Finamine tablets

taken Finamine tablets orally

DRUG

Placebo tablets

taken Placebo tablets orally

Sponsors & Collaborators

  • Yiling Pharmaceutical Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-15
Primary Completion
2018-04-27
Completion
2018-04-27

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04162275 on ClinicalTrials.gov