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Cariprazine: Comparison of Slow- and Immediate-release Forms

NCT02165098 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2016-03-24

No results posted yet for this study

Summary

The investigators are doing this study to compare blood levels and side effects of cariprazine when it's taken as one of two 'slow release' tablets, or as an 'immediate release' capsule. The investigators will also find out if food affects the absorption of cariprazine into the bloodstream after a 'slow release' tablet.

Conditions

  • Pharmacokinetic Profile

Interventions

DRUG

Cariprazine prolonged release tablet A

Cariprazine prolonged release tablet A - fasted

DRUG

Cariprazine prolonged release tablet B

Cariprazine prolonged release tablet B - fasted

DRUG

Cariprazine capsule

Cariprazine capsule - fasted

DRUG

Cariprazine PR tablet A

Cariprazine Prolonged Release tablet A - fed

DRUG

Cariprazine PR tablet B

Cariprazine Prolonged Release tablet B - fed

Sponsors & Collaborators

  • Gedeon Richter Plc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United Kingdom

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 NCT02165098 on ClinicalTrials.gov