Assessment of pharmacokinetic drug-drug interaction between pradigastat and acetaminophen in healthy subjects.
Purpose: The purpose of this study was to evaluate the effect of pradigastat, a diacylglycerol acyltransferase-1 inhibitor, on the pharmacokinetics of acetaminophen, a gastric emptying marker. Methods: Twenty-five healthy subjects were enrolled and received 1000 mg acetaminophen with meal in period...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 71; no. 4; pp. 425 - 433 |
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| Autores principales: | , , , , , , , |
| Formato: | pictorial research tables/charts Journal Article |
| Publicado: |
Springer Nature
Apr2015
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=103769635&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 103769635 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Apr2015 vid: 71 iid: 4 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 103769635 101501397 10.1007/s00228-015-1822-2 NLM25724644 103769635 ppf: 425 ppct: 8 formats: fmt: @attributes: type: P tig: atl: Assessment of pharmacokinetic drug-drug interaction between pradigastat and acetaminophen in healthy subjects. aug: au: Ayalasomayajula, Surya Meyers, Dan Koo, Phillip Salunke, Atish Majumdar, Tapan Rebello, Sam Sunkara, Gangadhar Chen, Jin affil: Novartis Institutes for BioMedical Research, East Hanover USA sug: subj: Drug Interactions Evaluation Acetaminophen Pharmacokinetics Acyltransferases Antagonists and Inhibitors Gastrointestinal Motility Human Confidence Intervals ROC Curve Random Sample Crossover Design Male Female Adult Middle Age Adverse Drug Event Descriptive Statistics Data Analysis Software Funding Source Adult: 19-44 years Middle Aged: 45-64 years Male Female ab: Purpose: The purpose of this study was to evaluate the effect of pradigastat, a diacylglycerol acyltransferase-1 inhibitor, on the pharmacokinetics of acetaminophen, a gastric emptying marker. Methods: Twenty-five healthy subjects were enrolled and received 1000 mg acetaminophen with meal in period 1, pradigastat (100 mg × 3 days followed by 40 mg × 7 days, 1 h before meal) in period 2, and 1000 mg acetaminophen at −2, −1, 0, +1, and +3 h with respect to meal timing in presence of steady-state pradigastat (40-mg maintenance dose) during periods 3-7. Results: The geometric mean ratio and 90 % confidence interval of Cmax and AUC of acetaminophen were within 80-125 % suggesting that the rate ad extent of acetaminophen were not affected when given at various time points with respect to pradigastat/meal timing. The acetaminophen Tmax was also not impacted under all treatment conditions but increased from 0.75 to 2.00 h when administered 1 h after food. Conclusion: In the presence of steady-state pradigastat, the pharmacokinetics of acetaminophen is unchanged, when given before, with, or 3 h after a meal. However, when given 1 h after a meal, the T of acetaminophen was delayed by ∼1.25 h without affecting C or AUC. pubtype: Academic Journal doctype: pictorial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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