Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese

• Register: ChiCTR
• Last refreshed on: 27 July 2020
• Main ID: ChiCTR2000034924
• Date of registration: 2020-07-24
• Prospective Registration: Yes
• Primary sponsor: The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
• Public title: Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese
• Scientific title: Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese
• Date of first enrolment: 2020-10-30
• Target sample size: Group 1 (single dose tolerance test):4;Group2(single dose tolerance test):6;Group3(single dose tolerance test):8;Group4(single dose tolerance test):8;Group 5(single dose tolerance test):8;Group 6(single dose tolerance test):8;Group 7 (multiple dose toler
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=47231
• Study type: Interventional study
• Study design: Parallel
• Phase: 1

Countries of recruitment

China

Contacts

• Name: Huang Yuhong
• Affiliation: The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

• Name: Wang Ruihua
• Affiliation: The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Key inclusion & exclusion criteria

Inclusion criteria: (1) Before the trial, the informed consent was signed, and the content, process and possible adverse reactions of the trial were fully understood;
(2) the study could be completed according to the requirements of the trial plan;
(3) the subjects (including male subjects) were willing to take effective contraceptive measures without family planning in the next six months;
(4) Chinese healthy subjects, male to female ratio 1:1, age 18-45 years (package) Including the critical value), the body weight of male and female subjects is not less than 50kg, BMI is between 19-24kg / m2 (including the critical value), and the body weight of the same batch of subjects is relatively close;
(5) health status: no history of clinical significance such as heart, liver, kidney, digestive tract, nervous system, respiratory system, mental disorders and metabolic abnormalities;
(6) comprehensive physical examination and physical and chemical examination are qualified, and female blood is acceptable Pregnancy is negative.
Exclusion criteria: (1) Female subjects taking contraceptives during menstruation, pregnancy, lactation and childbearing; subjects (including male subjects) who have family planning or can not take effective contraceptive measures within 6 months;
(2) Those who participated in other clinical trials within 3 months before the trial, or had blood transfusion and donation history (blood volume greater than 200ml) within 3 months before the trial;
(3) Those who smoked more than one cigarette per day or used a considerable amount of nicotine products in the three months before the test, and could not quit smoking during the test period, or those who were positive in the smoking test; or those who frequently drank alcohol in the six months before the test, that is, those who drank more than 14 units of alcohol per week (1 unit = 360ml of beer or 45ml of spirits or 150ml of wine with 40% of alcohol), or those who were positive in the alcohol test; or those who drank alcohol every day Tea, coffee and / or caffeinated beverages (more than 8 cups, 1 cup = 250ml);
(4) Those with allergic constitution, such as those with allergic history to two or more drugs or food, or those with allergic history to the components of the study drug (including but not limited to TGP, Xuebijing injection, kolbutol ? levofloxacin tablets);
(5) Subjects who could not tolerate high fat and high calorie meal 27 (2 boiled eggs 100g, 20g bacon, 1 piece of butter toast 50g, 115g fried potato chips, 240ml full fat milk) (this article was only applicable to subjects participating in the postprandial test);
(6) In the first 3 months of the trial, the drug that has been known to damage the liver, kidney and other organs was used; in the first month, the drug that has been used in the study was used; in the second week, the drug that had been used or had strenuous exercise or had significant changes in diet and exercise habits; in the first week, the Chinese medicine and medicated diet containing paeoniflorin and paeoniflorin were used; in the first day, the food that affects the activity of drug metabolizing enzyme was taken And drinks, including alcohol, caffeine, pitaya, mango, citrus fruits (including grapefruit), and other factors that may affect the absorption, distribution, excretion and metabolism of the test drug;
(7) In the first 2 weeks of the trial, the patients had used drugs that may cause gastrointestinal tract discomfort, or the patients had food environment factors and disease factors that may cause gastrointestinal tract discomfort;
(8) Patients with heart, liver, kidney and other important organs with primary disease, history of digestive tract disease (including dysphagia or any history affecting drug absorption), history of metabolic disease and history of nervous system disease;
(9) Hepatitis B five items (excluding surface antibody), hepatitis C antibody, syphilis test and HIV antibody test were positive; those who had a history of drug abuse, drug abuse test (morphine, methamphetamine, ketamine, dimethyldioxane, tetrahydrocannabinolic acid, cocaine) were positive, drug dependence or alcohol poisoning;
(10) Patients with abnormal vital signs (systolic blood pressure < 90mmHg or > 140mmHg, diastolic blood pressure < 60mmhg or > 90mmHg; heart rate < 60bpm or > 100bpm); patients with clinically significant abnormalities (including but not limited to physical examination, biochemical examination, coagulation, hematuria and stool routine examination, ECG, chest film, ult

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid arthritis, Sjogren's syndrome

Intervention(s)

Group 1 (single dose tolerance test):test drug or placebo;Group2(single dose tolerance test):test drug or placebo;Group3(single dose tolerance test):test drug or placebo;Group4(single dose tolerance test):test drug or placebo;Group 5(single dose tolerance test):test drug or placebo;Group 6(single dose tolerance test):test drug or placebo;Group 7 (multiple dose tolerance test) :test drug or placebo;Group 8 (multiple dose tolerance test):test drug or placebo;Group 9 (single dose pharmacokinetic test):test drug;Group 10 (single dose pharmacokinetic test):test drug;Group 11 (single dose pharmacokinetic test):test drug;Group 12 (single dose pharmacokinetic test):test drug;Group 13 (multiple dose pharmacokinetic test):test drug;Group 14 (food impact test):test drug;Group 15 (antibiotic effect test):test drug and levofloxacin tablets;

Primary Outcome(s)

QT/QTc interval;Tmax;Cmax;AUC;T1/2;

Source(s) of Monetary Support

self-raised funds

Ethics review

Status: Approved
Approval date: 28/11/2019
Contact:

Gu Xufang