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COMPLETED
NCT04667429
PHASE1

the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets

Sponsor: Sunshine Lake Pharma Co., Ltd.

View on ClinicalTrials.gov

Summary

Multiple Dose Safety, Tolerability, PK ,PD and Food Effect Study of HEC83518 in Healthy Subjects

Official title: A Phase I,Double-Blind, Placebo-Controlled, Multiple Oral Dose, Safety, Tolerability, Pharmacokinetics and Food Effect Study of HEC83518 Tablets in Healthy Chinese Subjects

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

57

Start Date

2021-01-18

Completion Date

2021-07-09

Last Updated

2026-05-01

Healthy Volunteers

Yes

Conditions

Interventions

OTHER

Food

HEC83518 40mg will be taken orally fasted or with food

DRUG

HEC83518

HEC83518 will be taken orally before sleep for 15 days

DRUG

placebo

The placebo will be administered before sleep for 15 days.

Locations (1)

The Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, China