Human Bioequivalence Test (Fasting & Postprandial) of Iloperidone Tablets

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.

Study Overview

• Status: Unknown
• Conditions: Bioequivalence
• Intervention / Treatment: Drug: Iloperidone 1 MG; Dietary supplement: fasting; Drug: Placebo; Dietary supplement: postprandial

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • The first affiliated hospital of zhengzhou university.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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	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.; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
AUC0-t、AUC0-∞	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.
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.
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.
λz	λz 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.

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2017
• Primary Completion (Actual): December 14, 2017
• Study Completion (Anticipated): March 14, 2018

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Iloperidone
• Other Study ID Numbers: ZDY2017002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No