Human Bioequivalence Test (Fasting & Postprandial) of Iloperidone Tablets

NCT ID: NCT03420534

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-17
• Study Completion Date: 2018-03-14

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.

Conditions

Bioequivalence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

iloperidone in fasting

iloperidone 1mg by mouth once for 6 days in the first cycle or the second cycle

Group Type: EXPERIMENTAL

Iloperidone 1 MG

Intervention Type: DRUG

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.

fasting

Intervention Type: DIETARY_SUPPLEMENT

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 tablets in fasting

placebo mimic iloperidone 1mg by mouth once for 6 days in the second cycle or the first cycle

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

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.

fasting

Intervention Type: DIETARY_SUPPLEMENT

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 tablets in postprandial

placebo mimic iloperidone 1mg by mouth once for 6 days

Group Type: ACTIVE_COMPARATOR

Iloperidone 1 MG

Intervention Type: DRUG

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

Intervention Type: DIETARY_SUPPLEMENT

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.

iloperidone in postprandial

iloperidone 1mg by mouth once for 6 days

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The first affiliated hospital of zhengzhou university.

Zhengzhou, Henan, China

Countries

China

Other Identifiers

ZDY2017002

Identifier Type: -

Identifier Source: org_study_id