Human Bioequivalence Test (Fasting & Postprandial) of Iloperidone Tablets

Bioequivalence Clinical Trial

Official title:

Human Bioequivalence Test (Fasting & Postprandial) of Iloperidone Tablets

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03420534
• Other study ID #: ZDY2017002
• Status: Active, not recruiting
• Phase: Phase 1
• First received: January 19, 2018
• Last updated: February 1, 2018
• Start date: November 17, 2017
• Est. completion date: March 14, 2018

Study information

• Verified date: January 2018
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: March 14, 2018
• Est. primary completion date: December 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bioequivalence

Intervention

Drug:
• Iloperidone 1 MG
An open, random, two-period and two-sequence cross-test design was adopted for the fasting and postprandial groups, and the randomization method was adopted for each subject to randomly take the subjects or reference preparations.
• Placebo
An open, random, two-period and two-sequence cross-test design was adopted for the fasting and postprandial groups, and the randomization method was adopted for each subject to randomly take the subjects or reference preparations.

Dietary Supplement:
• fasting
An open, random, two-period and two-sequence cross-test design was adopted for the fasting and postprandial groups, and the randomization method was adopted for each subject to randomly take the subjects or reference preparations.
• postprandial
An open, random, two-period and two-sequence cross-test design was adopted for the fasting and postprandial groups, and the randomization method was adopted for each subject to randomly take the subjects or reference preparations.

Locations

Country	Name	City	State
China	The first affiliated hospital of zhengzhou university.	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax,	Peak Plasma Concentration (Cmax) of iloperidone and metabolite P88	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.
Primary	Tmax	Tmax time to Peak Plasma Concentration (Cmax) of iloperidone and metabolite P88	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.
Primary	AUC0-t?AUC0-8	Area under the plasma concentration versus time curve (AUC) of iloperidone and metabolite P88	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.
Primary	t1/2,	t1/2, half-life period of iloperidone and metabolite P88	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.
Primary	F	F bioavalibility of iloperidone and metabolite P88	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.
Primary	?z	?z eliminating rate of iloperidone and metabolite P88	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.