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the human pharmacokinetic study of Panax quinquefolius between wall-breaking slices and traditional yinpian

The human pharmacokinetic study of Panax quinquefolius between wall-breaking slices and traditional yinpian

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-17011269
Enrollment
Unknown
Registered
2017-05-01
Start date
2017-04-20
Completion date
Unknown
Last updated
2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healhy subjects

Interventions

two:Panax quinquefolius

Sponsors

Clinical Pharmacology Institution, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. healthy volunteers aged 18 ~ 40 years old, including boundary value; With the group of age are not more than 10 years apart; 2. body mass index (BMI) subjects between 19 and 24 kg/m2,With the group of weight are not more than 10% of average weight; 3. physical examination without exception discoverer; 4. Vital signs and electrocardiogram examination no obvious abnormalities found; blood pressure in the normal range, sitting systolic blood pressure of 100 - 140mmHg, and sitting diastolic pressure of 60 - 90mmHg; heart rate = 45 times / min and = 100 times / min; 5. All laboratory tests were within the normal reference range, or by the investigator, no significant abnormality; 6. subjects volunteered for the experiment and is willing to test in accordance with the provisions of this test procedure; 7. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. It is known to be allergic or allergic to the test drug and any of its ingredients or related drugs; 2. within 4 weeks before test had clinical significance of the disease or received surgery; 3. any existing laboratory results of clinical significance of abnormal situation; 4. (Such as kidney or liver damage, severe coronary heart disease, congestive heart failure, cerebrovascular disease, hepatitis B or hepatitis C, acquired immunodeficiency syndrome (AIDS), Or cancer or an unstable clinical finding based on the researcher's judgment that may have a negative impact on the study drug treatment or the negative effects of the study drug treatment; 5. Any medications were taken within 2 weeks before screening; 6. participants attended more than 3 clinical trials in the first 1 years of screening, or screened in the first 4 months of the opening of the drug trial, or screened in the first 3 months to participate in the approved drug test; 7. test before 3 months to participate in blood donors; 8. Had a history of alcohol abuse, more than a bottle of beer per day; 9. Smokers (smoking more than 5 cigarettes per day) and 2 weeks before taking the medicine to stop smokers ; 10. The researchers judged that the subjects had poor compliance and could not complete the test as required; 11. Ongoing medical treatment of patients with concomitant treatment; 12. Cough with phlegm, edema or slobber state in patients with eczema; 13. Menstrual women; 14. Pregnant or planning pregnancy; 15. 3 months before and during the trial, the use of soft drugs such as marijuana, or hard drugs (e.g., cocaine, benzene, etc) before and during the year before the trial.

Design outcomes

Primary

MeasureTime frame
medicine generation power curve;

Countries

China

Contacts

Public ContactZhirong Tan

Clincal Pharmacology Institution, Central South University

tanzr@163.com+86 13907496238

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026