Who is sponsoring NCT01942382?

NCT01942382 is sponsored by Janssen Pharmaceutical K.K..

What condition does NCT01942382 study?

NCT01942382 studies Schizophrenia.

What drugs are being tested in NCT01942382?

Interventions: Paliperidone palmitate.

What is the status of NCT01942382?

NCT01942382 is currently COMPLETED.

Last reviewed 2013-09-10 · How we verify

Clinical Pharmacology Study of JNS010 (Paliperidone Palmitate) in Subjects With Schizophrenia

NCT01942382 Phase 1 COMPLETED

The purpose of this study is to evaluate the pharmacokinetics (study of what the body does to a drug) and safety of paliperidone palmitate ranging from 75 to 150 milligram equivalents in repeated doses (4 injections) administered in the deltoid muscle (muscle in the shoulder) or gluteal muscle (group of muscles present in the buttocks) in participants with schizophrenia.

Details

Lead sponsor	Janssen Pharmaceutical K.K.
Phase	Phase 1
Status	COMPLETED
Enrolment	76
Start date	2009-04
Completion	2010-03

Conditions

Schizophrenia

Interventions

Paliperidone palmitate

Primary outcomes

Plasma concentration of unchanged drug (Paliperidone palmitate) — Days 1 to 190
Plasma concentration of active metabolite (paliperidone) — Days 1 to 190
Plasma concentration of enantiomer of paliperidone palmitate (R078543) — Days 1 to 190
Plasma concentration of enantiomer paliperidone palmitate (R078544) — Days 1 to 190
Maximum Observed Plasma Concentration (Cmax) of paliperidone palmitate — Days 1 to 190
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of paliperidone palmitate — Days 1 to 190
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.