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The Safety, Tolerability, and Pharmacokinetics Study of HEC113995 PA•H2O Tablets in Healthy Subjects

NCT04591301 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2020-10-28

No results posted yet for this study

Summary

The Safety, Tolerability and Pharmacokinetics Study of HEC113995 PA•H2O Tablets in Healthy Male and Female Subjects

Conditions

Interventions

DRUG

HEC113995 PA•H2O tablets

Each dose of HEC113995 PA•H2O tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

DRUG

Placebo tablets

Placebo tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

Sponsors & Collaborators

  • Sunshine Lake Pharma 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
2019-07-04
Primary Completion
2019-12-06
Completion
2019-12-06

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT04591301 on ClinicalTrials.gov