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Assessment of Pharmacokinetic Drug-Drug Interaction between Pradigastat and Acetaminophen in Healthy Subjects

Ayalasomayajula, Surya and Meyers, Charles and Koo, Phil and Salunke, Atish Azad and Majumdar, Tapan and Rebello, Sam and Sunkara, Gangadhar and Chen, Jin (2015) Assessment of Pharmacokinetic Drug-Drug Interaction between Pradigastat and Acetaminophen in Healthy Subjects. European Jouranl of Clinical Pharmacology.

Abstract

The effect of pradigastat, a diacylglycerol acyltransferase-1 inhibitor, on the pharmacokinetics of acetaminophen, a gastric emptying marker, was evaluated. Twenty-five healthy subjects were enrolled and received 1000 mg acetaminophen with meal in Period 1, pradigastat (100 mg x 3 days followed by 40 mg x 7 days, one hour before meal) in Period 2, and 1000 mg acetaminophen at -2, -1, 0, +1, and +3 hours with respect to meal timing) in presence of steady-state pradigastat (40 mg maintenance dose) during Periods 3-7. The rate and extent of acetaminophen exposure were not affected when given at various time points with respect to pradigastat/meal timing. The Tmax of acetaminophen increased from 0.75 hours to 2.00 hours without affecting Cmax and AUC when administered one hour after food. Therefore, pradigastat is unlikely to affect the pharmacokinetics of drugs whose absorption is dependent on the rate of gastric emptying when co-administered.

Item Type: Article
Keywords: Pharmacokinetics, drug-drug interaction, pradigastat, acetaminophen, paracetamol, gastric motility
Date Deposited: 27 Apr 2016 23:45
Last Modified: 27 Apr 2016 23:45
URI: https://oak.novartis.com/id/eprint/23356

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