Human pharmacokinetic study of Guhong injectio

Phase 1

Recruiting

• Conditions: ot applicable

• Registration Number: ITMCTR2100004763
• Lead Sponsor: Shanghai Institute of Materia Medica, CAS; Second Affilitated Hospital of Tianjin University of TCM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged between 18 and 35 years.
2. The weight of all subjects must be greater than 50 kg, and the body mass index should not exceed 15% of the ideal value. Body mass index = weight (kg)/height (m) squared (body mass index is between 19 and 24).
3. General physical examination, laboratory, physical and chemical examinations are all normal.
4. The subject agreed to inform them to eat food and medicine within 1 week.
5. According to GCP regulations, obtain informed consent and take the test voluntarily.

Exclusion Criteria

1. Subjects who had primary disease in key organs including heart, liver and kidneys, or had a history of gastrointestinal disease, metabolic disease or neurological disease.
2. Subjects who had mental or physical disability, or subjects with a history of lunacy.
3. Subjects with clinically significant abnormalities in physical examination, biochemistry, blood and urine analysis, electrocardiography, chest X-ray, or ultrasound screening.
4. Subjects with a history of drug dependence, drug abuse or alcoholism.
5. Subjects with physical allergy or known allergic to Honghua, Guhong ingredients and product (including other drugs).
6. Subjects who took herbal medicines or food or beverage containing Honghua or aceglutamide.
7. Subjects who participated any other investigational drug study within four week prior to this study.
8. Subjects who took any medication with known damaging effects on main organs within three months prior to this study, or took any over-the-counter or prescription drugs within two week prior to this study.
9. Subjects with hemorrhagic tendency.
10. Menstrual, pregnant or breast-feeding women and women at childbearing age take oral contraceptive.
11. Subjects with abnormal vital signs (systolic blood pressure <90 mmHg or >140 mmHg, or diastolic blood pressure < 50 mmHg or > 90 mmHg, or heart rate < 50 bpm or >100 bpm).
12. Subjects who frequently took alcohol with six months (i.e., more than 14 Units of alcohol every week) or took more than one cigarette every day with three months prior to this study.
13. Subjects who took any soft drugs (e.g., marijuana) with three month or took any hard drugs (e.g., cocaine, phencyclidine, etc) with one year prior to this study.
14. Subjects with risk factors that possibly influence the absorption, disposition, excretion and metabolism.
15. Subjects who donate blood within three month prior to this study.
16. In the opinion of the investigator, subjects who are not suitable to participate in the study for whatever reasons must be excluded.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
plasma concentration;urine concentration;