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
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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