None
Conditions
Interventions
Fed T-R group:Each subject takes orally 2µg of the test preparation in the first cycle, 2µg of the reference preparation orally in the second cycle.
Fed R-T group:Each subject takes orally 2µg of the reference preparation in the first cycle, 2µg of the test preparation orally in the second cycle.
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) Positive results of hepatitis B surface antigen, hepatitis C antibody, and HIV antibody or syphilis; 16) Consumption of chocolate or any food/beverage containing caffeine or rich in xanthine within 48 h before check-in; 17) Consumption of any products containing alcohol within 24 h before check-in, or a positive result of the alcohol breath test; 18) 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; 19) A positive result of the pregnancy test, or in lactation during screening or the test period for female participants; 20) Not able to tolerate yellow light or no natural light for a long period of time; 21) Not able to swallow multiple or larger tablets/capsules at one time; 22) Not able to tolerable on venipuncture, or a history of fainting on acupuncture and/or blood; 23) Have special requirements for diet and can not follow the unified diet; 24) Outdoor work or work requiring prolonged exposure to sunlight or recent exposure to outdoor workers; 25) A history of urinary tract stones; 26) Unable to participate in this trial for participants’ own reasons; 27) 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 |
|---|---|
| baseline corrected Cmax;baseline corrected AUC0-t;baseline corrected AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| baseline uncorrected Cmax;baseline uncorrected AUC0-t;baseline uncorrected AUC0-8;AE, SAE, Vital sign, laboratory results; | — |
Countries
China
Contacts
Public ContactShen Huixia
Henan (Zhengzhou) Zhonghui Cardiovascular Hospital
Outcome results
None listed