NCT03420534

Human Bioequivalence Test (Fasting & Postprandial) of Iloperidone Tablets

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
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	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.
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.

Timeline

• Start date: 2017-11-17
• Primary completion: 2017-12-14
• Completion: 2018-03-14
• First posted: 2018-02-05
• Last updated: 2018-02-05

Locations

1 site across 1 country: China