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
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.
Exclusion Criteria:
iloperidone 1mg by mouth once for 6 days in the first cycle or the second cycle
Drug: Iloperidone 1 MG · Dietary Supplement: fasting
placebo mimic iloperidone 1mg by mouth once for 6 days in the second cycle or the first cycle
Drug: Placebo · Dietary Supplement: fasting
placebo mimic iloperidone 1mg by mouth once for 6 days
Drug: Iloperidone 1 MG · Dietary Supplement: postprandial
iloperidone 1mg by mouth once for 6 days
Drug: Placebo · 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.