To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Food Effects of LY03021 in Healthy Chinese Subjects
NCT07371065 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 98
Last updated 2026-01-27
Summary
This is a multicenter, randomized withdrawal, double-blind, parallel, placebo-controlled design clinical trial of Toludesvenlafaxine Hydrochloride Extended-Release Tablets to evaluate the long-term efficacy and safety in the treatment of Chinese patients with depression.
Conditions
Interventions
- DRUG
-
LY03021
Orally only once
- DRUG
-
Orally only once
Sponsors & Collaborators
-
Luye Pharma Group Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-10-28
- Primary Completion
- 2026-04-30
- Completion
- 2026-04-30
Countries
- China
Study Locations
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