Steady-state pharmacokinetics of controlled release and immediate release formulations of remoxipride in patients with chronic schizophrenia

Twenty-four stable, chronic schizophrenic inpatients were entered in a double-blind crossover study designed to compare single dose and steady state pharmacokinetic profiles of an immediate release formulation (IR) 200 mg BID and a controlled release formulation (CR) of remoxipride 400 mg once daily...

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Bibliographic Details
Published in:Psychopharmacology 1990-01, Vol.101 (1), p.132-136
Main Authors: Tench, D, Soni, S D, Ashwood, T, Movin, G
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Antipsychotic Agents - administration & dosage
Antipsychotic Agents - pharmacokinetics
Antipsychotic Agents - therapeutic use
Benzamides - administration & dosage
Benzamides - pharmacokinetics
Benzamides - therapeutic use
Biological Availability
Chronic Disease
Delayed-Action Preparations
Double-Blind Method
Female
Humans
Male
Middle Aged
Prolactin - blood
Psychiatric Status Rating Scales
Randomized Controlled Trials as Topic
Remoxipride
Schizophrenia - drug therapy
Schizophrenia - metabolism
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Summary:Twenty-four stable, chronic schizophrenic inpatients were entered in a double-blind crossover study designed to compare single dose and steady state pharmacokinetic profiles of an immediate release formulation (IR) 200 mg BID and a controlled release formulation (CR) of remoxipride 400 mg once daily. The rate of absorption of remoxipride CR was significantly lower than the IR formulation and tmax was prolonged from 1.3 to 7.9 h after a single dose and from 2.2 to 6.0 h after repeated dosing. Although the single dose of remoxipride CR was twice as large as the single dose of the IR, the Cmax was similar for both formulations after a single dose. However, the Cmax at steady state was slightly lower for CR. There was significantly less fluctuation in plasma concentrations at steady state with the CR formulation, although the average plasma concentration of remoxipride IR and CR was similar. The mean relative bioavailability with regard to the amount of remoxipride absorbed after remoxipride CR 400 mg once daily compared to IR 200 mg BID was 97%. It was concluded that the CR formulation is suitable for a once-daily administration from a pharmacokinetic point of view.
ISSN:0033-3158
1432-2072
DOI:10.1007/BF02253730