Hyperphosphatemia
Conditions
Interventions
Group 1:to take the investigational product(0.75g) after the meal and only once
Group 2:to take the investigational product(1.5g) after the meal and only once
pre-test group:to take the investigational product(3g) after the meal and only once
Group 3:to take the investigational product(3g) after the meal and only once
Group 4:to take the investigational product(4.5g) after the meal and only once
Group 5:to take the investigational product(6g) after the meal and only once
Group 6:to take the investigational product(9g) after the meal and only once
the group of the food's influence(3gB group, 3gC group):The 3gB group was given 3g on an empty stomach in the first cycle and 3g on a high-fat and high-calorie meal in the second cycle. 3g group C was
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1) sign the ICF before the clinical trial, and have a full understanding of the test content, process and possible adverse reactions; 2) able to complete the research in accordance with the requirements of the test scheme; 3) subjects (including partners) are willing to voluntarily take effective contraceptive measures within 6 months from the screening to the last study drug administration, and the specific contraceptive measures are shown in the appendix; 4) male and female subjects aged 18-50 years (including 18-50 years old); 5) the weight of the male subject shall not be less than 50kg, and that of the female subject shall not be less than 45kg. Body mass index (BMI) = weight (kg)/height 2 (m2), body mass index in the range of 18 to 28kg/m2 (including the critical value); 6) The results of physical examination and vital signs examination are normal or abnormal without clinical significance; 7) The indexes of inorganic phosphorus in blood biochemical examination are within the reference range.
Exclusion criteria
Exclusion criteria: 1) smoking more than 5 cigarettes a day in the 3 months before the clinical trial; 2) allergy (multiple drug and food allergies, especially seafood allergies); 3) have a history of drug and/or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL beer, 25 mL spirits, or 100ml wine); 4) blood donation or massive blood loss within the first three months of screening (> 450ml); 5) within 14 days before the screening taken any prescription drugs, over-the-counter medications, vitamins or herbal products, such as lanthanum ion release may have effects of drugs, such as proton pump inhibitors, and have an impact on drug combination of drugs, such as ciprofloxacin hydrochloride, thyroxine, lithium, etc., and affect the excretion of drugs, such as rhubarb, sorbitol and containing cationic laxatives, etc.; 6) Those who have taken special diet (including pitaya, mango, grapefruit, etc.) or had strenuous exercise or other factors affecting drug absorption, distribution, metabolism and excretion within 2 weeks before the screening period; 7) recent major changes in diet or exercise habits; 8) have taken investigational product or participated in clinical trials of drugs within the first three months of screening period; 9) a history of dysphagia or any gastrointestinal disease that affects drug absorption; 10) suffering from any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers; 11) subjects who cannot tolerate standard meals (two boiled eggs, one piece of buttered bacon toast, one box of Fried potato chips, and one cup of full-fat milk) (this article is only applicable to those who participate in the study of the influence of food on pharmacokinetics and pharmacodynamics); 12) The results of ECG examination were abnormal and clinically significant; 13) the female subjects are lactating or have positive results of serum pregnancy during the screening period or during the clinical trial; 14) Abnormal results of clinical laboratory examination have clinical significance, Or other clinically significant diseases (including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immunity, mental or cardiovascular diseases) found within 12 months prior to the screening period; 15) Viral hepatitis (including hepatitis B and C), AIDS antibodies, treponema pallidum antibodies screening positive; 16) Acute illness or concomitant medication occurred from the screening stage to the time before the study medication was taken; 17) Intake of chocolate, any caffeinated or xanthine-rich foods or beverages within 24 hours prior to check-in; 18) Take any alcoholic products within 24 hours prior to check-in; 19) Urine drug screening test results are positive, or have a history of drug abuse and used drugs in the past five years; 20) subjects considered by the investigator to have other factors unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma lanthanum concentrations;Urinary phosphate concentrations;Urinary lanthanum concentrations;Feces lanthanum concentrations; | — |
Countries
China
Contacts
Public ContactXiaoyan Wen
Liaoning Grand Nuokang Biopharmaceuticcal Co.,LTD
Outcome results
None listed