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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

NCT04162275•Yiling Pharmaceutical Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Age: 18 to 65 years old (including the upper and lower limits).
•2. Male or female
•3. Weight ≥50kg, BMI 18-28 kg/m2 (including the upper and lower limits).
•4. Understand and sign the informed consent form，able to understand the process and requirements of the study, and volunteer to participate in this study.

Exclusion Criteria

•If being one of the following conditions, subjects cannot be selected
•1. There is a history of disease in heart, liver, kidney, respiratory system, digestive tract, nervous system, endocrine system, immune system, blood system, etc., that the investigator has determined to be clinically significant;
•2. Abnormalities are in vital signs, comprehensive physical examinations, laboratory tests, ECG examinations, etc., and they are considered clinically significant by the investigator;
•3. Any drug was taken within two weeks prior to dosing in the study , and the investigators believe that this condition may affect the assessment results of this study;
•4. There is an seriously allergic history of food and drug or hypersensitivity that the investigator has identified as clinically significant;
•5. There are positive results of serological tests (HBsAg, anti-HCV, anti-HIV, or TP-Ab) during screening;
•6. Within 1 years prior to the administration of the drug, the history of drinking or drug abuse, that the investigator believes it may affect the evaluation results of the study. Or, during screening, the alcohol breath test or the urine screening test is positive.
•7. Subjects cannot quit smoking or quit drinking during the study period or subjects' carbon monoxide breath test is ≥7ppm during the screening period (when the investigator thinks it necessary, it can be further confirmed by urine cotinine test);
•8. Subjects participated in any drug clinical trial within 3 months prior to study dosing;
•9. Subjects donated blood ≥400mL or 2 units within 3 months prior to study dosing;
+3 more criteria

Locations (1)

Shijiazhuang Yiling Pharmaceutical Co. Ltd

Shijiazhuang, Hebei, China

Key Dates

Start Date

August 15, 2017

Primary Completion Date

April 27, 2018

Completion Date

April 27, 2018

Last Updated

December 14, 2021

Enrollment

ACTUAL participants

Conditions

Parkinson Disease

Interventions

Finamine tablets

DRUG

Placebo tablets

DRUG

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Autonomic FailurePure Autonomic Failure+3 more

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 14, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

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