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

NCT04667429 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2026-05-01

No results posted yet for this study

Summary

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

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.

Sponsors & Collaborators

  • Sunshine Lake Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-01-18
Primary Completion
2021-07-09
Completion
2021-07-09

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT04667429 on ClinicalTrials.gov