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Midazolam Drug-Drug Interaction Study With Lurasidone HCl

2014-07-23 21:09:54 | BioPortfolio

Summary

A Phase I, Drug-Drug Interaction Study between Midazolam and Lurasidone HCl.

Description

lurasidone 120 mg, midazolam 5 mg

To compare the single-dose pharmacokinetic profile of midazolam 5 mg when administered alone vs. when administered with a single-dose of lurasidone 120 mg.

To compare the single dose pharmacokinetic profile of midazolam 5 mg when administered alone vs. when administered after steady state dosing with lurasidone 120 mg.

Study Design

Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Conditions

Schizophrenia Patients

Intervention

Lurasidone HCl

Location

CCT/Parexel
Culver City
California
United States
90232

Status

Completed

Source

Dainippon Sumitomo Pharma America

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:54-0400

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PubMed Articles [24018 Associated PubMed Articles listed on BioPortfolio]

Short-term efficacy and tolerability of lurasidone in the treatment of acute schizophrenia: A meta-analysis of randomized controlled trials.

Lurasidone, an azapirone derivative, is a novel second generation antipsychotic with potent binding affinity for dopamine D2, serotonin 5-HT, 5-HT 5-HT and noradrenaline alpha receptors. This updated ...

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Prior studies suggest that the inflammatory biomarker c-reactive protein (CRP) holds promise for predicting antidepressant response in patients with major depressive disorder. The objective of this st...

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Medical and Biotech [MESH] Definitions

A thiazole derivative and atypical ANTIPSYCHOTIC AGENT that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST; SEROTONIN 5-HT2 RECEPTOR ANTAGONIST, serotonin 5-HT7 receptor antagonist, and antagonist of the adrenergic α2A and α2C receptors, as well as a partial SEROTONIN 5-HT1A RECEPTOR AGONIST. It is used in the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER.

A chronic form of schizophrenia characterized primarily by the presence of persecutory or grandiose delusions, often associated with hallucination.

A type of schizophrenia characterized by abnormality of motor behavior which may involve particular forms of stupor, rigidity, excitement or inappropriate posture.

A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309)

An obsolete concept, historically used for childhood mental disorders thought to be a form of schizophrenia.

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