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Status unknownNCT03420534Updated Feb 5, 2018

Human Bioequivalence Test (Fasting & Postprandial) of Iloperidone Tablets

A Phase 1 interventional study of Iloperidone 1 MG and Placebo in Bioequivalence, sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-05.

Sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bioequivalence
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.
  1. 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

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.
  1. 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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    iloperidone in fasting

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

    Drug: Iloperidone 1 MG · Dietary Supplement: fasting

  • 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 · Dietary Supplement: fasting

  • Active comparator
    placebo tablets in postprandial

    placebo mimic iloperidone 1mg by mouth once for 6 days

    Drug: Iloperidone 1 MG · Dietary Supplement: postprandial

  • Experimental
    iloperidone in postprandial

    iloperidone 1mg by mouth once for 6 days

    Drug: Placebo · Dietary Supplement: postprandial

Interventions

  • DrugIloperidone 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.

  • DrugPlacebo

    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 supplementfasting

    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 supplementpostprandial

    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.

05

What researchers measure

Primary outcomes

  1. Cmax,

    Peak Plasma Concentration (Cmax) of iloperidone and metabolite P88

    Time frame: 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.

  2. Tmax

    Tmax time to Peak Plasma Concentration (Cmax) of iloperidone and metabolite P88

    Time frame: 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.

  3. AUC0-t、AUC0-∞

    Area under the plasma concentration versus time curve (AUC) of iloperidone and metabolite P88

    Time frame: 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.

  4. t1/2,

    t1/2, half-life period of iloperidone and metabolite P88

    Time frame: 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.

  5. F

    F bioavalibility of iloperidone and metabolite P88

    Time frame: 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.

  6. λz

    λz eliminating rate of iloperidone and metabolite P88

    Time frame: 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.

06

Study locations

1 site
  • The first affiliated hospital of zhengzhou university.
    Zhengzhou, Henan 450000, China
07

Registry details

Key details

Study ID
NCT03420534
Lead sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Responsible party
Sponsor
First posted
Feb 5, 2018
Start date
Nov 17, 2017
Primary completion
Dec 14, 2017
Completion
Mar 14, 2018 (estimated)
Last update
Feb 5, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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