Bioequivalence among three methods of administering pantoprazole granules in healthy subjects.
PURPOSE: The bioequivalence among three methods of administering pantoprazole granules was studied in healthy subjects. METHODS: In this randomized, open-label, three-period, crossover study, 25 healthy adults received a single 40-mg dose of pantoprazole granules with applesauce orally, with apple j...
| Publicado en: | American Journal of Health-System Pharmacy Vol. 66; no. 21; pp. 1923 - 1929 |
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| Autores principales: | , , , |
| Formato: | clinical trial equations & formulas research tables/charts Journal Article |
| Publicado: |
Oxford University Press / USA
11/1/2009
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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=105339619&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 105339619 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10792082 1X3 jtl: American Journal of Health-System Pharmacy issn: 10792082 maglogo: N pubinfo: dt: 11/1/2009 vid: 66 iid: 21 pid: 622 pub: Oxford University Press / USA artinfo: ui: 105339619 2010455955 10.2146/ajhp080118 NLM19850786 105339619 ppf: 1923 ppct: 6 formats: fmt: @attributes: type: P tig: atl: Bioequivalence among three methods of administering pantoprazole granules in healthy subjects. aug: au: Tammara B Weisel K Katz A Meng X affil: Early Development and Clinical Pharmacology, Wyeth Research, Collegeville, PA 19426, USA; tammarab@wyeth.com sug: subj: Administration, Oral Methods Pantoprazole Sodium Pharmacokinetics Adult Analysis of Variance Apple Chromatography, Liquid Clinical Trials Confidence Intervals Data Analysis Software Descriptive Statistics Funding Source Male Models, Statistical One-Tailed Test Pantoprazole Sodium Adverse Effects Pantoprazole Sodium Blood Pennsylvania Regression Repeated Measures Mass Spectrometry Human Adult: 19-44 years Male ab: PURPOSE: The bioequivalence among three methods of administering pantoprazole granules was studied in healthy subjects. METHODS: In this randomized, open-label, three-period, crossover study, 25 healthy adults received a single 40-mg dose of pantoprazole granules with applesauce orally, with apple juice orally, and with apple juice administered via a nasogastric tube. Subjects were randomly assigned to one of six treatment sequences. Blood samples were collected within 2 hours before treatment administration on study day 1 and at 0.33, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours after treatment administration. Plasma pantoprazole concentrations were analyzed by a validated liquid chromatography-tandem mass spectrometry method. The plasma pantoprazole concentration-time data for each subject were analyzed using noncompartmental methods. The 90% confidence intervals (CIs) for the test:reference geometric mean ratio were calculated for the peak pantoprazole concentration (C(max) ) and area under the concentration-time curve (AUC). RESULTS: Of the 25 subjects enrolled, 100% completed the study. The mean C(max) and AUC values were similar for the three administration methods. The 90% CIs for the ratios of the geometric means of the granules in apple juice orally (92.4-112.5%) and in apple juice administered through a nasogastric tube (102.7-125.2%), relative to the granules administered with applesauce orally, were essentially within the bioequivalent limits of 80-125%. No serious adverse events or study discontinuations occurred. CONCLUSION: Three methods of administering pantoprazole delayed-release granules for oral suspension-with apple juice orally, with applesauce orally, and with apple juice through a nasogastric tube--were bioequivalent in healthy subjects. pubtype: Academic Journal doctype: clinical trial equations & formulas research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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