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(searched for: Food Enhanced Pharmacokinetics for Clinical Translation of Low Dose Abiraterone Acetate in Metastatic Castration-Resistant Prostate)
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Meenakshi Meenu, Ranjit Kumar Sahoo, Amlesh Seth, Ujjalkumar Das, Thirumurthy Velpandian, Dharamvir Singh Arya
Journal of Cancer Science and Clinical Therapeutics, Volume 4, pp 314-324; doi:10.26502/jcsct.5079074

Abstract:
Introduction: Abiraterone acetate (AAc) is prescribed in metastatic castration-resistant prostate cancer (mCRPC) with recommendation to administer in fasted state due to food-drug interaction. This study was designed to compare pharmacokinetics of 250 mg AAc in fed state with 1000 mg in fasted state for use of low dose AAc as a cost-effective alternative. Patients and Methods: A randomized, open label, nonreplicated crossover clinical study was conducted after ethics approval and trial registration. Eighteen patients were randomized into two groups: 1. Test- 250 mg AAc in fed state (milk, 7% fat); 2. Reference-1000 mg AAc in fasted state. Drug was administered for 6 days and on 7th day, blood samples were withdrawn at predose, 1, 2, 3, 4 and 6 hours. Patients were crossed-over to other groups and process was repeated. Abiraterone levels in plasma were estimated using liquid chromatography–mass spectrometry. Maximum (Cmax) and minimum (Cmin) plasma concentrations, area under curve from 0 to 6 hours (AUC0- 6) were estimated and appropriate statistical tests were applied. Results: Seventeen mCRPC patients completed the study. Difference in mean Cmax between test (107.86 ng/mL) and reference (88.71 ng/mL) was not statistically significant (p>0.05) so was the difference in mean AUC0-6 (p>0.05). Trough plasma concentrations had statistically significant (p
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