Status:
UNKNOWN
Research on the Physiological Characteristics of the Gastrointestinal Tract in Chinese Volunteers
Lead Sponsor:
Dongyang Liu
Conditions:
Endoscopy, Gastrointestinal
Eligibility:
All Genders
18-60 years
Brief Summary
The dissolution and absorption of oral drugs in the gastrointestinal tract is a complex process, which is affected by physiological factors such as transporters, metabolic enzymes, gene phenotypes, ga...
Detailed Description
This is a single-center, open-labelled study. Twenty four Chinese adult volunteers who schedule for gastrointestinal endoscopy will be enrolled and will be not allowed to take products containing grap...
Eligibility Criteria
Inclusion
- Chinese volunteers who are planning to undergo digestive endoscopy;
- Volunteers who have a full understanding of the content, process and possible adverse reactions of the study and have signed an informed consent form before the clinical trial;
- Volunteers who are able to complete the clinical trial according to the protocol;
- Male and female volunteers between the ages of 18 and 60 (including both ends) on the date of signing the consent form;
- Female volunteers are non-pregnant or non-lactating women, and will live asexually after enrollment until the end of the trial;
- Male volunteers weigh no less than 50 kg, female volunteers weigh no less than 45 kg, and the body mass index (BMI) of male and female volunteers within the range of 19.0-26.0 kg/m2 (including cut-off values);
- The comprehensive physical examination, routine laboratory examinations are normal or abnormal, but the investigator judges that there is no clinical significance;
- Volunteers who are able to abstain from alcohol, coffee, non-prescription drugs or prescription drugs, and no food and beverages related to grapefruit within 14 days before the start of the test until the end of the test;
- Volunteers have no history of smoking
Exclusion
- Volunteers who disagree with "No food or beverages containing caffeine, xanthine and alcohols such as grapefruit-containing products, juice, tea, coffee, wine, etc., 14 days before endoscope", "No smoking 14 days before endoscope";
- Volunteers who do not comply with the relevant regulations about endoscope;
- Volunteers with endoscope contraindications;
- Volunteers with HCV, HIV, HBsAg and/or syphilis positive antibody;
- Volunteers with allergic physique;
- Volunteers with needlesickness, blood phobia, difficult in collecting blood and in tolerating local anesthesia;
- Females who are pregnant, breastfeeding, or taking birth control pills for less than 3 months;
- Volunteers have bleeding disorders, or therapeutic anticoagulation (warfarin, aspirin, clopidogrel, traditional Chinese medicine, etc.), or anesthesia dependence or alcohol dependence;
- Volunteers have the smoking history, alcoholism history, alcohol screening positive, drug screening positive, history of drug abuse in the past five years or administration drugs in the three months prior to the trial;
- Alcoholics (14 units of alcohol consumed per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine) and volunteers who cannot prohibition from the time of enrollment to the end of the study;
- Volunteers who have a history of gastrointestinal disease with a definite severity or have diseases that have been considered unsuitable for participating in this study by researchers;
- Volunteers with obvious gastrointestinal discomfort within 6 months before the start of the clinical trial;
- Volunteers who have undergone gastrointestinal and liver surgery and those who have received any other surgery 6 months before the clinical trial;
- The clinical laboratory examination is abnormal and the researchers judges that it has clinical significance;
- Volunteers who have taken any clinical trial drugs within 3 months;
- Volunteers who have used any antibiotics within 3 months;
- Volunteers who have used any drug within 1 month;
- Volunteers with hypertension （systolic blood pressure\>139 mmHg，diastolic blood pressure\>89 mmHg);
- Volunteers with Parkinson's disease or family history of Parkinson's disease;
- Volunteers with a family history of sudden cardiac death or arrhythmia;
- Habitual drink, including coffee, tea, grapefruit juice and so on;
- Significant weight loss recently;
- Researcher judge that the volunteer has other factors that are not suitable for participating in this study, regardless of their severity
Key Trial Info
Start Date :
October 31 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04743726
Start Date
October 31 2020
End Date
September 1 2022
Last Update
February 8 2021
Active Locations (1)
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1
Dongyang Liu
Beijing, China, 100191