Preoperative bowel cleaning preparation
Conditions
Interventions
TCIC-001 Group 1(Phase I):40g(TCIC-001) +2000mL(WATER)
TCIC-001 Group 2 (Phase I):60g(TCIC-001) +2000mL(WATER)
TCIC-001 Group 3 (Phase I):80g(TCIC-001) +2000mL(WATER)
TCIC-001 Group 4 (Phase I):40g(TCIC-001) +1500mL(WATER)
TCIC-001 Group 5 (Phase I):60g(TCIC-001) +1500mL(WATER)
TCIC-001 Group 6 (Phase I):80g(TCIC-001) +1500mL(WATER)
Control group (Phase I):4 boxes of Sutaiqing +3000mL water
TCIC-001 Group 1 (Phase II):Dominant combination 1 (TBD) Depending on phase I results
TCIC-001 Group 2 (Phase II):Dominant combination 2 (TBD) Depending on phase I results
TCIC-001 Group 3 (Phase II):Dominant combination 3 (TBD) Depending on phase I results
Control group (Phase II):4 boxes of Sutaiqing +3000mL water
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-70 years (including the boundary value,when the informed consent is signed) who intend to undergo colonoscopy , both male and female; 2. The subjects were judged to be in good overall health by the investigator based on their medical history, physical examination during screening, vital signs, 12-lead electrocardiogram, laboratory tests (blood routine, urine routine, blood biochemistry (including electrolytes), coagulation function), serum virology, and chest radiograph (normal or abnormal); 3. Reliable contraceptive methods will be available during the trial period and for 3 months after completion of the trial; 4. Subjects who can communicate well with researchers, fully understand the purpose, nature, method and possible adverse reactions of the experiment, understand and obey the requirements of the experiment, and voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects who have a history of drug or other allergies, or who are likely to be allergic to the test drug or any component of the test drug as determined by the investigator; 2. Those who cannot take medication as required by the program, including those who cannot comply for mental reasons (such as epileptic patients or patients with a history of epilepsy); 3. Use of study drugs or other intestinal prepreparations or drugs that affect gastrointestinal dynamics within 7 days before the start of the trial; Use of drugs that affect kidney function, use of drugs that increase the risk of fluid retention or electrolyte disturbances, or that may increase the risk of potential complications; 4. Severe constipation with suspected severe gastric motility disorder; 5. Difficulty swallowing; 6. Gastrointestinal hemorrhage or gastrointestinal stenosis; 7. Gastrointestinal obstruction or perforation, intestinal obstruction or gastric retention; 8. Severe active inflammatory bowel disease or toxic megacolon; 9. Disturbance of consciousness; 10. Subjects who have previously received major gastrointestinal surgery (such as colostomy, colectomy, gastric bypass, gastric septal surgery) or need major gastrointestinal surgery; 11. Previous electrolyte disturbances, dehydration, severe chronic renal failure, and severe cardiac failure (grade 3 or 4 cardiac function); 12. Liver and kidney insufficiency, transaminase, bilirubin, creatinine more than 1.5 times the normal value; 13. Female subjects who tested positive for pregnancy during the screening period or baseline period or were lactating; 14. Participated in clinical trials of other drugs and used other clinical drugs within 3 months prior to receiving the investigational drug; 15. Subjects with non-negative human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface (HBsAg) antigen positive, hepatitis C antibody (HCV-Ab) positive, or treponema pallidum antibody (TP-Ab) positive serum virology test during screening; 16. Any other circumstances which, in the opinion of the investigator, may affect the subject's informed consent or adherence to the test protocol, or the subject's participation in the test may affect the test results or his or her own safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy;Pharmacokinetics (Phase I only); | — |
Countries
China
Contacts
Public ContactPinghong Zhou, Xuening Li
Zhongshan Hospital, Fudan University
Outcome results
None listed