Parallel Group, Multiple Dose Pharmacokinetics Study of Five Antipsychotic Medications in Psychiatric Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

305

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

October 31, 2014

Study Completion Date

December 31, 2014

Conditions
Psychotic DisordersSchizophreniaBipolar DisorderDepressive Disorder
Interventions
DRUG

Aripiprazole, oral formulation

Aripiprazole tablets will be administered orally (by mouth), at no dose restriction, as per the locally approved label indications.

DRUG

Olanzapine, oral formulation

Olanzapine tablets will be administered orally, at no dose restriction as per the locally approved label indications.

DRUG

Paliperidone, oral formulation

Paliperidone prolonged-release/extended-release (XR) formulation tablets will be administered orally, at no dose restriction, as per the locally approved label indications.

DRUG

Paliperidone, LAI

Paliperidone long-acting injectable (LAI) i.e., paliperidone palmitate injections, will be administered per the locally approved label indications.

DRUG

Quetiapine, oral formulation

Quetiapine immediate-release (IR) formulation or extended-release (XR) formulation tablets will be administered orally, at no dose restriction, as per the locally approved label indications.

DRUG

Risperidone, oral formulation

Risperidone tablets will be administered orally, at no dose restriction, as per the locally approved label indications.

DRUG

Risperidone, LAI

Risperidone LAI injections will be administered will be administered per the locally approved label indications.

Trial Locations (24)

Unknown

Garden Grove

Kissimmee

Atlanta

Hoffman Estates

Cedarhurst

Austin

Banfield

Buenos Aires

Córdoba

La Plata

Aalst

Antwerp

Brussels

Kortenberg

Rio de Janeiro

Valinhos

Burgas

Berlin

Hamburg

Lübeck

Badajoz

Barcelona

Torrevieja

Zamora

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02087579 - Parallel Group, Multiple Dose Pharmacokinetics Study of Five Antipsychotic Medications in Psychiatric Participants | Biotech Hunter | Biotech Hunter