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The human pharmacokinetic study of Salvia miltiorrhiza between wall-breaking slices and traditional yinpian

The human pharmacokinetic study of Salvia miltiorrhiza between wall-breaking slices and traditional yinpian

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-16008757
Enrollment
Unknown
Registered
2016-07-01
Start date
2016-06-28
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Healthy subjects

Interventions

two:Reference and controlled drugs

Sponsors

Clinical Pharmacology Institution, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. healthy volunteers, 18 ~ 40 years old, including boundary value;With the group of age are not more than 10 years apart; 2. greater than 50 kg weight, body mass index (BMI) subjects between 19 and 24 kg/m2, including boundary value, with batch weight difference should not be different; 3. physical examination without exception discoverer; 4. there is no history of drug allergy; 5. a smoke-free, alcohol hobby; 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. within 4 weeks before test had clinical significance of the disease or received surgery; 2. any existing laboratory results of clinical significance of abnormal situation; 3. used within three months of a known viscera damage drugs or drugs currently in use; 4. has a history of drug allergy and highly sensitive to the environment material;Of salvia miltiorrhiza and allergy to any ingredient or drugs; 5. was susceptible to disease of hypokalemia; 6. congestive heart failure, gastric ulcer, glucose - 6 - phosphate dehydrogenase (G6PD) deficiency, severe liver function damage, severe kidney damage; 7. any other clinical history of severe disease or cardiovascular system, endocrine system, nervous system disease or lung, hematology, immunology, history of psychiatric disease and metabolic abnormalities, etc; 8. recent cold; 9. with active bleeding, diseases such as diabetes, glaucoma; 10. testing positive for HIV; 11. test positive for hepatitis b surface antigen or hepatitis c testing positive for; 12. are associated with treatment of any medical significance, the 13. to attend within 14 days before the test is associated with people; 14. has a history of drug abuse; 15. during 3 months before the test and test taking soft drugs (such as marijuana) or test a year before and during the test to take hard drugs (such as cocaine, benzene piperidine, etc.); 16. participants attended other drugs within three months; 17. test before 3 months to participate in blood donors; 18. with blood coagulation dysfunction or thromboembolic disorders. 19. The stomach is cold.

Design outcomes

Primary

MeasureTime frame
medicine generation power curve;

Countries

China

Contacts

Public Contactzhirong Tan

Clinical Pharmacology Institution, Central South University

tanzr@163.com+86 13907496238

Outcome results

None listed

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