BioequivalencePhase 1NCT03420534
Human Bioequivalence Test (Fasting & Postprandial) of Iloperidone Tablets
A Phase 1 study testing Iloperidone 1 MG, fasting and postprandial in people with Bioequivalence, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Iloperidone 1 MG, fasting and postprandial
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2017to 14 Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of zhengzhou university.
Zhengzhou, Henan, 450000
About this study
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
- Being tested
- Iloperidone 1 MG, Placebo, fasting, postprandial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iloperidone 1 MGDrug
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.
PlaceboDrug
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.
fastingDietary 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.
postprandialDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| iloperidone in fasting | Experimental | iloperidone 1mg by mouth once for 6 days in the first cycle or the second cycle Receives: Drug: Iloperidone 1 MG; Dietary Supplement: fasting |
| placebo tablets in fasting | Active comparator | placebo mimic iloperidone 1mg by mouth once for 6 days in the second cycle or the first cycle Receives: Drug: Placebo; Dietary Supplement: fasting |
| placebo tablets in postprandial | Active comparator | placebo mimic iloperidone 1mg by mouth once for 6 days Receives: Drug: Iloperidone 1 MG; Dietary Supplement: postprandial |
| iloperidone in postprandial | Experimental | iloperidone 1mg by mouth once for 6 days Receives: Drug: Placebo; Dietary Supplement: postprandial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,
Peak Plasma Concentration (Cmax) of iloperidone and metabolite P88
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start17 Nov 2017
- Primary completion14 Dec 2017
- Study completion14 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420534
- Sponsor's protocol ID
- ZDY2017002
- Status last verified
- Jan 2018
- First submitted
- 19 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Bioequivalence Test (Fasting & Postprandial) of Iloperidone Tablets
- ClinicalTrials.gov ID
- NCT03420534
- Acronym / sponsor ID
- ZDY2017002
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 14 Dec 2017 (actual)
- Study completion
- 14 Mar 2018 (estimated)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| iloperidone in fasting | Experimental | Drug: Iloperidone 1 MG, Dietary Supplement: fastingiloperidone 1mg by mouth once for 6 days in the first cycle or the second cycle |
| placebo tablets in fasting | Active comparator | Drug: Placebo, Dietary Supplement: fastingplacebo mimic iloperidone 1mg by mouth once for 6 days in the second cycle or the first cycle |
| placebo tablets in postprandial | Active comparator | Drug: Iloperidone 1 MG, Dietary Supplement: postprandialplacebo mimic iloperidone 1mg by mouth once for 6 days |
| iloperidone in postprandial | Experimental | Drug: Placebo, Dietary Supplement: postprandialiloperidone 1mg by mouth once for 6 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iloperidone 1 MGAn 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 | iloperidone in fasting, placebo tablets in postprandial |
| PlaceboAn 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 | iloperidone in postprandial, placebo tablets in fasting |
| fastingAn 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 | iloperidone in fasting, placebo tablets in fasting |
| postprandialAn 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 | iloperidone in postprandial, placebo tablets in postprandial |
Primary outcome
Cmax,
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.
Peak Plasma Concentration (Cmax) of iloperidone and metabolite P88
Tmax
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 time to Peak Plasma Concentration (Cmax) of iloperidone and metabolite P88
AUC0-t、AUC0-∞
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.
Area under the plasma concentration versus time curve (AUC) of iloperidone and metabolite P88
t1/2,
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, half-life period of iloperidone and metabolite P88
F
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 bioavalibility of iloperidone and metabolite P88
λz
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 eliminating rate of iloperidone and metabolite P88
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
Related trials for Bioequivalence
Not yet recruitingPhase 1
A Study of Imlunestrant (LY3484356) in Healthy Female Participants
Healthy
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingPhase 1
Bioequivalence Study Between YHP2508B and YHR2602 in Healthy Subjects
Healthy Subjects (HS)
Active, not recruitingPhase 1
A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Iloperidone 1 MG, fasting and postprandial in people with Bioequivalence, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax, (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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.