Human Bioequivalence Test (Fasting & Postprandial) of Iloperidone Tablets

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03420534

Collaborator

(none)

Enrollment

Location

Arms

3.8

Anticipated Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bioequivalence	Drug: Iloperidone 1 MG Drug: Placebo Dietary Supplement: fasting Dietary Supplement: postprandial	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Human Bioequivalence Test (Fasting & Postprandial) of Iloperidone Tablets

Actual Study Start Date :

Nov 17, 2017

Actual Primary Completion Date :

Dec 14, 2017

Anticipated Study Completion Date :

Mar 14, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: iloperidone in fasting iloperidone 1mg by mouth once for 6 days in the first cycle or the second cycle	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. 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.
Active Comparator: placebo tablets in fasting placebo mimic iloperidone 1mg by mouth once for 6 days in the second cycle or the first cycle	Drug: 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.
Active Comparator: placebo tablets in postprandial placebo mimic iloperidone 1mg by mouth once for 6 days	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. Dietary Supplement: 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.
Experimental: iloperidone in postprandial iloperidone 1mg by mouth once for 6 days	Drug: 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: 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.

Outcome Measures

Primary Outcome Measures

Cmax, [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.]
Peak Plasma Concentration (Cmax) of iloperidone and metabolite P88
Tmax [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.]
Tmax time to Peak Plasma Concentration (Cmax) of iloperidone and metabolite P88
AUC0-t、AUC0-∞ [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.]
Area under the plasma concentration versus time curve (AUC) of iloperidone and metabolite P88
t1/2, [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.]
t1/2, half-life period of iloperidone and metabolite P88
F [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.]
F bioavalibility of iloperidone and metabolite P88
λz [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.]
λz eliminating rate of iloperidone and metabolite P88

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The first affiliated hospital of zhengzhou university.	Zhengzhou	Henan	China	450000

Sponsors and Collaborators

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

ClinicalTrials.gov Identifier:

NCT03420534

Other Study ID Numbers:

ZDY2017002

First Posted:

Feb 5, 2018

Last Update Posted:

Feb 5, 2018

Last Verified:

Jan 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Iloperidone

Study Results

No Results Posted as of Feb 5, 2018