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Comparative Bioavailability Study of Aripiprazole 10 mg Oral Soluble Film vs Abilify® 10 mg Tablet in Healthy Volunteers

NCT02501109 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-03-24

No results posted yet for this study

Summary

The purpose of this study is to compare the rate and extent of absorption of Aripiprazole Oral Soluble Film 10 mg (Test) versus Abilify® 10 mg tablet (Reference) in healthy male volunteers

Conditions

Interventions

DRUG

Aripiprazole

Healthy volunteers will receive Aripiprazole Oral Soluble Fim(OSF) 10mg orally a single of dose within 28 days

Sponsors & Collaborators

  • CMG Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Byung Jo Kim, M.D. · Development Div.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-02-29
Completion
2016-03-31

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Entities

Diseases

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 NCT02501109 on ClinicalTrials.gov