Pharmacokinetic affection of Sailuotong capsule on metabolic enzymes

Phase 1

Completed

• Conditions: vascular dementia

• Registration Number: ITMCTR2000004150
• Lead Sponsor: Affiliated Beijing Chaoyang Hospital of Capital Medical University

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: Completed
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1) Han male subjects who are completely healthy after medical history and physical examination.
2) Age: Within the 18-40 age group, the age difference is no more than 10 years.
3) During the screening, the body mass index (BMI) is within 19-24 kg/m^2 (included). Overweight or underweight persons should be avoided. Generally, the body weight should not be less than 50kg.
4) During screening, the clinical laboratory examination, electrocardiogram, chest X-ray are normal, or the abnormality is judged by the researcher to have no clinical significance.
5) Good compliance, able to participate in the test in accordance with the program throughout the test process, and willing to accept follow-up.
6) Written informed consent was signed before the test.

Exclusion Criteria

1) A history of drug abuse.
2) Those who have participated in other drug clinical trials within 3 months.
3) If the participant has used or intends to use non-prescription drugs, prescription drugs, health care products or Chinese herbal medicines within 14 days before the administration of the drug, it is up to the investigator to determine whether the participant is included or not.
4) Multiple doses of drugs that may affect the activity of drug metabolizing enzymes such as barbiturate, cimetidine, phenytoin and rifampicin within 2 weeks before the trial.
5) Alcoholics who consume an average of more than 14 units of alcohol per week or fail to comply with the alcohol restriction requirements during the study period (1 unit = 200 mL of 5% alcohol beer or 25 mL of 40% alcohol white wine or 83 mL of 12% alcohol wine).
6) Smokers (who smoke more than 10 cigarettes a day).
7) Those who could not give up smoking during the whole experiment.
8) Tea and coffee consumption greater than 1 L/ day.
9) Blood donation or blood loss of more than 200 ml within 3 months.
10) Allergic constitution (allergic to more than two kinds of drugs, food and pollen).
11) Have a history of cardiovascular, respiratory, liver, kidney, digestive tract, endocrine, blood or neuropsychiatric diseases or have the above diseases.
12) Positive for hepatitis B and/or hepatitis B virus surface antigen.
13) Positive for hepatitis C and/or hepatitis C antibodies.
14) HIV infection and/or HIV antibody positive.
15) If the subject's spouse has been preparing for pregnancy in the past 5 months.
16) Those with bleeding tendency.
17) Slow metabolizing genotypes of metabolic enzymes CYP2C9,2C19 and 2D6.
18) Subjects considered by other researchers to be unable to be enrolled.Any complication of clinical significance occurs.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
pharmacokinetics;

Secondary Outcome Measures

Name	Time	Method
Safety evaluation;