The beneficial effect of calcitriol in renal osteodystrophy appears to result from correction of hypocalcemia and secondary hyperparathyroidism
Conditions
Interventions
Fasting T-R group:Each subject takes orally 2µg of test preparation or reference preparation in fasting state every period.
Fasting R-T group:Each subject takes orally 2µg of test preparation or reference preparation in fasting state every period.
Sponsors
Henan (Zhengzhou)Zhonghui Cardiovascular Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Able to give signed Informed Consent Form before the trial, and fully understand the trial content, process and possible adverse drug reactions (ADRs); 2) Able to complete the trial in compliance with the protocol; 3) Participants (including males) willing to adopt effective contraceptive methods and with no pregnancy plan (no sperm or egg donation plan) from 14 days before screening to 3 months after discharge from the trial in period 2; 4) Males and females between 18 and 55 years old, inclusive; 5) At least 50 kg for males, 45 kg for females, with a Body Mass Index (BMI) = Weight/Height2 (kg/m2) between 19.0-26.0 kg/m2, inclusive; 6) No history of cardiac, hepatic, renal, digestive tract, nervous system, mental and metabolic disorders, etc. Only those who meet all the criteria listed above can be enrolled.
Exclusion criteria
Exclusion criteria: 1) With = 5 cigarettes per day on average within 3 months before screening, or not able to quit smoking during the trial; 2) Allergic constitution, or allergic to the drug components and its analogues; 3) A history of alcohol abuse (alcohol consumption of more than 14 units per week : 1 unit of alcohol = 285 mL beer, or 25 mL spirits, or 100 mL wine); 4) Blood donation or massive blood loss (= 400 mL) within 3 months before check-in, or any blood donation plan from screening until 1 month after the last administration; 5) A history of dysphagia, or any gastrointestinal disease and surgery which may affect the drug absorption; 6) Any drugs that affect the absorption and metabolism of calcitriol within 30 days before check-in, such as Vitamin D and its derivatives, phenytoin/phenobarbital, ketoconazole, phosphate-binding agents, thiazide diuretics, digitalis drugs, magnesium-containing drugs (e.g., antacids), hormonal drugs, bile acid chelators such as sevelamer, cholestyramine; 7) Any drugs that affect the activity of liver enzymes within 30 days before check-in; 8) Any prescription medication taken within 14 days before check-in; 9) Any over-the-counter (OTC) medication or herbal medicine or health supplementary within 7 days before check-in; 10) Consumption of any special diets (such as grapefruit), or strenuous exercise engagement, or have any other factors affecting drug absorption, distribution, metabolism and excretion within 7 days before check-in; 11) Participation in other drug clinical trials within 3 months before check-in; 12) Any clinically significant abnormality findings, as judged by a clinical physican, such as physical examination, vital signs, electrocardiogram and laboratory tests; 13) The creatinine clearance rate is lower than 80 mL/min; (the calculation formula in section 8.3.4) 14) Abnormalities of thyroid and parathyroid function, as well as abnormalities of calcium and phosphorus metabolism, especially those who may have hypercalcemia; 15) Severe 25-(OH)D3 deficiency indicated by Vitamin D examination; 16) Positive results of hepatitis B surface antigen, hepatitis C antibody, and HIV antibody or syphilis; 17) Consumption of chocolate or any food/beverage containing caffeine or rich in xanthine within 48 h before check-in; 18) Consumption of any products containing alcohol within 24 h before check-in, or a positive result of the alcohol breath test; 19) A positive result of the drug abuse test, or a history of drug abuse in the past 5 years, or intake of any narcotic drugs within 3 months prior to the trial; 20) A positive result of the pregnancy test, or in lactation during screening or the test period for female participants; 21) Not able to tolerate yellow light or no natural light for a long period of time; 22) Not able to swallow multiple or larger tablets/capsules at one time; 23) Not able to tolerable on venipuncture, or a history of fainting on acupuncture and/or blood; 24) Have special requirements for diet and can not follow the unified diet; 25) Outdoor work or work requiring prolonged exposure to sunlight or recent exposure to outdoor workers; 26) A history of urinary tract stones; 27) Unable to participate in this trial for participants’ own reasons; 28) Other conditions in which participants are not suitable for the trial determined by investigators. Those who meet any of the criteria listed above must not be enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactShen Huixia
Henan (Zhengzhou)Zhonghui Cardiovascular Hospital
Outcome results
None listed