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Tolerability and Pharmacokinetics of Hypidone Hydrochloride in Healthy Subjects

NCT04598607 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-08-25

No results posted yet for this study

Summary

This study will investigate the tolerability and pharmacokinetics of Hypidone Hydrochloride by multiple doses in 36 healthy male and female subjects who are of 18 to 55 years old.

Conditions

Interventions

DRUG

Hypidone Hydrochloride tablets

30mg(10mg×3), 40mg(10mg×4) or 50mg(10mg×5) Hypidone Hydrochloride tablets will be given orally once on day 1, day 9 and twice a day on day 3\~8.

DRUG

Placebo

3, 4 or 5 tablets of placebo will be given orally once on day 1, day 9 and twice a day on day 3\~8.

Sponsors & Collaborators

  • Zhejiang Huahai Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-10-30
Primary Completion
2021-01-11
Completion
2021-01-15

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 NCT04598607 on ClinicalTrials.gov