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Bioequivalence Study of Bosiqing and ABILIFY Under Fasting/Fed Condition

NCT03232710 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2017-07-28

No results posted yet for this study

Summary

To compare the rate and extent of absorption of Aripiprazole Orally disintegrating tablets 10 mg of Chengdu Kanghong Pharmaceutical Group Co.,Ltd, China and ABILIFY (Aripiprazole) 10 mg orodispersible tablets of Otsuka Pharmaceutical Europe Ltd. in healthy, adult, human subjects under fasting/fed condition as well as to monitor the safety and tolerability of subjects.

Conditions

  • Bioequivalence

Interventions

DRUG

Bosiqing

Aripiprazole Orally disintegrating tablets 10mg

DRUG

abilify

Aripiprazol orodispersible tablets 10mg

Sponsors & Collaborators

  • Chengdu Kanghong Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-26
Primary Completion
2018-04-30
Completion
2018-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03232710 on ClinicalTrials.gov