Completed INTERVENTIONAL NCT04667429

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

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

Sponsor: Sunshine Lake Pharma Co., Ltd.

Conditions Insomnia

Interventions Food HEC83518 placebo

Updated 6 times since 2021 Last updated: Apr 27, 2026 Started: Jan 18, 2021 Primary completion: Jul 9, 2021 Completion: Jul 9, 2021

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04667429, this observational or N/A phase trial focuses on Insomnia and remains completed. Sponsored by Sunshine Lake Pharma Co., Ltd., it has been updated 6 times since 2021, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

6 versions recorded

May 4, 2026 — Present [daily]

Completed

Status: Unknown → Completed · Phase: PHASE1 → None
Sep 2024 — May 2026 [monthly]

Unknown PHASE1
Jul 2024 — Sep 2024 [monthly]

Unknown PHASE1

Status: Unknown Status → Unknown
Jan 2023 — Jul 2024 [monthly]

Unknown Status PHASE1

Status: Recruiting → Unknown Status
Jun 2021 — Jan 2023 [monthly]

Recruiting PHASE1

Status: Not Yet Recruiting → Recruiting

▶ Show 1 earlier version

Jan 2021 — Jun 2021 [monthly]

Not Yet Recruiting PHASE1

First recorded

Eligibility Summary

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

Contact Information

Sponsor contact:

Sunshine Lake Pharma Co., Ltd.

Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Shanghai, China