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GW117 ODT （Orally Disintegrating Tablets） Safety and Pharmacokinetics Study in Healthy Subjects

NCT06964711 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-05-09

No results posted yet for this study

Summary

To evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of GW117 ODT in healthy volunteers

Conditions

Interventions

DRUG

GW117 ODT

Sublingual route ， 0.5mg/1mg/2mg/4mg，QD

DRUG

Placebo

GW117 Placebo matching for Sublingual route ，QD

Sponsors & Collaborators

  • Beijing Greatway Pharmaceutical Technology Co.,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
2021-07-12
Primary Completion
2023-03-24
Completion
2023-03-24

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 NCT06964711 on ClinicalTrials.gov