Effect of food on the pharmacokinetics of lurasidone: results of two randomized, open-label, crossover studies
| Autor: | Sheldon H. Preskorn, Yu-Yuan Chiu, Larry Ereshefsky, Antony Loebel, Nagaraju Poola |
|---|---|
| Rok vydání: | 2013 |
| Předmět: |
medicine.medical_specialty
Meal business.industry digestive oral and skin physiology Cmax Confidence interval Bioavailability Psychiatry and Mental health Endocrinology Neurology Pharmacokinetics Internal medicine medicine Pharmacology (medical) Neurology (clinical) Geometric mean Open label business Lurasidone medicine.drug |
| Zdroj: | Human Psychopharmacology: Clinical and Experimental. 28:495-505 |
| ISSN: | 0885-6222 |
| DOI: | 10.1002/hup.2338 |
| Popis: | Objective This study aimed to investigate the effect of prandial status and caloric and fat composition of meals on the pharmacokinetics of lurasidone. Methods Two randomized, open-label, crossover studies were conducted in clinically stable adults with schizophrenia or schizoaffective disorder. Study 1 (n = 16) evaluated the effect of fasting and three meal types (100 kcal/medium fat, 200 kcal/medium fat, and 800–1000 kcal/high fat), and Study 2 (n = 26) evaluated the effect of fasting and five meal types (350 kcal/high fat, 500 kcal/low fat, 500 kcal/high fat, 800–1000 kcal/low fat, and 800–1000 kcal/high fat) on the bioavailability of lurasidone. Subjects received lurasidone 120 mg once daily. Maximum serum concentration (Cmax) and area under the serum concentration–time curve over the dosing interval (AUC0–tau) were determined on Day 5 for each meal type. Results In Study 1, the geometric mean Cmax in the fasted state was 56.7 ng/mL compared with 123.0 ng/mL for the 800- to 1000-kcal meal; mean AUC0–tau was 360.0 versus 752.4 ng·h/mL (both p |
| Databáze: | OpenAIRE |
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