A Study to Evaluate the Tolerability and Pharmacokinetics of Jiashen Tablets in Healthy Subjects

NCT04164290 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-11-23

No results posted yet for this study

Summary

Jiashen Tablets as an oral, compound traditional chinese medicine prepatations, have an effect on improvement of the heart failure. This study will assess the safety, tolerability and pharmacokinetics (PK) of Jiashen Tablets, following oral administration of single and multiple ascending dose of Jiashen Tablets.

Conditions

  • Healthy

Interventions

DRUG

Jiashen Tablets

1 tablet

DRUG

Jiashen Tablets

2 tablets

DRUG

Jiashen Tablets

4 tablets

DRUG

Jiashen Tablets

6 tablets

DRUG

Jiashen Tablets

8 tablets

DRUG

Jiashen Tablets

9 tablets

DRUG

Jiashen Tablets Placebo

1 tablet

DRUG

Jiashen Tablets Placebo

2 tablets

DRUG

Jiashen Tablets Placebo

4 tablets

DRUG

Jiashen Tablets Placebo

6 tablets

DRUG

Jiashen Tablets Placebo

8 tablets

DRUG

Jiashen Tablets Placebo

9 tablets

Sponsors & Collaborators

  • Tasly Pharmaceutical Group Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Rui Liu · Tasly Group, Co. Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-06-29
Primary Completion
2021-04-09
Completion
2021-04-09

Countries

  • China

Study Locations

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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 NCT04164290 on ClinicalTrials.gov