Clinical trial NCT03420534: Human Bioequivalence Test (Fasting & Postprandial) of Iloperidone Tablets
Official title: Human Bioequivalence Test (Fasting & Postprandial) of Iloperidone Tablets
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Bioequivalence
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: to inspect relevant pharmacokinetic parameters and relative exploitation degree, with fasting and postprandial dosing bioequivalence test under the condition of the human body, provide the basis for registration filing.


Eligibility criteria: Inclusion Criteria:

- 1) age above 18 years of age (including 18 years of age), male or female; 2) body mass index (BMI) = weight (kg)/height 2 (m2) , body mass index (including critical value) within 18\~26 range; 3) health: no heart, liver, kidney, gastrointestinal tract, nervous system, mental disorder and metabolic abnormalities, such as history, physical examination showed the blood pressure, heart rate, ecg, respiratory system, liver, kidney, and normal or abnormal urinalysis performed without clinical significance; 4) subjects (including male subjects) are willing to take effective contraceptive measures in the next three months without pregnancy plan.

5) sign the informed consent before the test, and fully understand the contents, procedures and possible adverse reactions of the test; 6) be able to complete the research according to the test plan.

Exclusion Criteria:

- 1) HBsAg, HBeAg, HCV antibody, HIV antibody, and treponema pallidum are positive; 2) general physical examination, blood biochemistry, blood urine routine, serum prolactin and ECG examination are abnormal and have clinical significance; 3) past history or current in clinic with heart, breathing, endocrine, metabolism, kidney, liver, gastrointestinal tract, skin, infection, malignant tumor, blood and nerve system disease or mental/disorders; 4) take any medication, including over-the-counter and herbal medicines, within two weeks prior to the start of the trial; 5) the subjects' drinking history was more than 14 units of alcohol per week (1 unit = beer 285 mL, or liquor 25 mL, or wine 150 mL) or alcohol breath test was positive; 6) currently smoking \>5 per day; 7) drug abuse or drug dependence or urine drug screening positive; 8) blood donation or a large amount of blood loss (\>400 mL) or as a subject participating in drug trial sampling in the last three months; 9) underwent surgery within 4 weeks prior to the trial, or planned to perform surgical procedures during the study period; 10) test within 48 h before taking any special diet (including grapefruit, etc.), and/or contain xanthine diet or strenuous exercise, or other affect drug absorption, distribution, metabolism and excretion of food or drink, etc.; 11) drink excessive amounts of tea, coffee and/or caffeinated beverages (8 cups or more, 1 cup =250 mL) per day; 12) QTc period is greater than 450ms (male) or 470ms (female), or there is a history of QTc extension; 13) postural hypotension (the systolic blood pressure drops by 20mmHg or diastolic blood pressure drops by 10mmHg after standing on the supine position) 14) during the screening period or during the test, the female subjects were positive in lactation or pregnancy.

15) the researchers judged that the subjects' ability to comply with the research requirements was not necessarily complete or not necessarily able to comply with the subjects required by the test.

Primary outcomes:
measure: Cmax,
timeFrame: Change from Baseline afer dosing 0.33h,0.67h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,12h ,24h,36h,48h,72h,96h,120h.
measure: Tmax
timeFrame: Change from Baseline afer dosing 0.33h,0.67h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,12h ,24h,36h,48h,72h,96h,120h.
measure: AUC0-t、AUC0-∞
timeFrame: Change from Baseline afer dosing 0.33h,0.67h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,12h ,24h,36h,48h,72h,96h,120h.
measure: t1/2,
timeFrame: Change from Baseline afer dosing 0.33h,0.67h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,12h ,24h,36h,48h,72h,96h,120h.
measure: F
timeFrame: Change from Baseline afer dosing 0.33h,0.67h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,12h ,24h,36h,48h,72h,96h,120h.
measure: λz
timeFrame: Change from Baseline afer dosing 0.33h,0.67h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,12h ,24h,36h,48h,72h,96h,120h.
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The first affiliated hospital of zhengzhou university.
state: Henan
Study officials:
References: