NCT02165098

Cariprazine: Comparison of Slow- and Immediate-release Forms

A Single-Dose Study to Evaluate the Pharmacokinetic, Safety, Tolerability Profile and the Effects of Food on the Pharmacokinetics of Different Formulations of Cariprazine in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Gedeon Richter Plc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Comparison of blood levels and side effects of cariprazine when it's taken as one of two 'slow release' tablets, or as an 'immediate release' capsule. We'll also find out if food affects the absorption of cariprazine into the bloodstream after a 'slow release' tablet.

Conditions

• Pharmacokinetic Profile

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-06-17
• Last updated: 2016-03-24

Locations

1 site across 1 country: United Kingdom