Cariprazine: Comparison of Slow- and Immediate-release Forms

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gedeon Richter Plc.
• Treatments: Cariprazine

Criteria

Inclusion Criteria:

• Healthy Caucasian males aged 18-55 years with body mass index (BMI) ≥ 18 kg/m2 and ≤ 30 kg/m2

• Have a semisupine pulse rate ≥ 40 bpm and ≤ 100 bpm during the vital sign assessment at screening and on admission (Day 1)

• Agree to use an effective method of contraception and not have their partners become pregnant throughout the study and for up to 4 months after the administration of the IMP, or have been sterilized for at least 1 year

Exclusion Criteria:

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