Cariprazine: Comparison of Slow- and Immediate-release Forms

Sponsor
Gedeon Richter Plc.
Study ID
NCT02165098
Phase
PHASE1
Status
Completed

Conditions

  • Pharmacokinetic Profile

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 30, 2014
Status verified
Mar 2016
Primary completion
Feb 29, 2016
Completion
Feb 29, 2016

Study Design

Enrollment
160 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cariprazine PR tablet B
    Cariprazine prolonged release tablet B - fed
  • Experimental: Cariprazine PR tablet A
    Cariprazine prolonged release tablet A - fed
  • Experimental: Cariprazine capsule
    Cariprazine capsule - fasted
  • Experimental: Cariprazine prolonged release tablet B
    Cariprazine prolonged release tablet B - fasted
  • Experimental: Cariprazine prolonged release tablet A
    Cariprazine prolonged release tablet A - fasted

Primary Outcome Measure

C[max] [ Time Frame: 0-672 hours ]