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A Clinical Study Trial of Phenlarmide in China | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Clinical Study Trial of Phenlarmide in China

A Randomized, Double-blind, Placebo-controlled, Single-dose, Multiple-dose, Incremental Tolerance and Pharmacokinetics Study of Phenlarmide Tablets in Chinese Healthy Adult Volunteers

NCT04164121•Yiling Pharmaceutical Inc.

View on ClinicalTrials.gov

Summary

1. To evaluate the tolerance and safety of FLA tablets in healthy volunteers. 2. To evaluate the pharmacokinetics of FLA tablets in healthy volunteers. 3. Provide basis for dosage setting for follow-up clinical research.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1)18-65 years old (including upper and lower limits);
•2)Men and women are not limited;
•3)Men weigh more than 50 kg, women weigh more than 45 kg, BMI 19-28 kg/m2 (including upper and lower limits);
•4)Understand and sign the informed consent, understand the research process and requirements, and volunteer to participate in this study.

Exclusion Criteria

•1)There is a history of heart, liver, kidney, respiratory, digestive tract, nervous system, endocrine, immune or hematological diseases judged by researchers as having clinical significance;
•2)There are abnormalities in vital signs, general physical examination, laboratory examination and ECG examination, which are judged to be of clinical significance by researchers;
•3)Any drug was taken within two weeks before the study was administered, and the researchers believe that this condition may affect the evaluation results of the study;
•4)There is a significant history of drug allergy or hypersensitivity in food that researchers have identified as clinically significant;
•5)The positive results of serological tests (HBsAg, anti-HCV, anti-HIV or TP-Ab) were found at the time of screening;
•6)One year before the study was administered, some researchers believed that alcohol or drug abuse history might affect the results of this study, or that alcohol breath test or urine drug screening test were positive during screening;
•7)Those who had smoking history within three months before the first administration or who had positive urinary cotinine test in screening stage;
•8)Those who participated in any clinical trial within 3 months before administration;
•9)Those who donated blood more than 400 mL or 2 units within 3 months before administration;
•10)Do not agree to avoid the use of tobacco, alcohol or caffeine-containing beverages within 24 hours before and during the trial, or to avoid vigorous exercise, or to avoid other factors affecting drug absorption, distribution, metabolism and excretion;
+2 more criteria

Locations (1)

Peking union medical college hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

December 17, 2019

Primary Completion Date

December 2, 2020

Completion Date

December 2, 2020

Last Updated

December 14, 2021

Enrollment

ACTUAL participants

Conditions

Parkinson Disease

Interventions

Phenlarmide Tablets

DRUG

Placebos

DRUG

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

View study

RECRUITINGPHASE1

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

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

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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 Clinical Study Trial of Phenlarmide in China

Inclusion Criteria

Exclusion Criteria

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

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

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations