NCT04164121

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Yiling Pharmaceutical Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Phenlarmide Tablets	Oral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17.
DRUG	Placebos	Oral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17.

Timeline

• Start date: 2019-12-17
• Primary completion: 2020-12-02
• Completion: 2020-12-02
• First posted: 2019-11-15
• Last updated: 2021-12-14

Locations

1 site across 1 country: China