Pharmacokinetic interaction between linagliptin and tadalafil in healthy Egyptian males using a novel LC–MS method / Sara S Mourad, Eman I El-Kimary, Magda A Barary, Dalia A Hamdy
Aim:Assessment of pharmacokinetic interaction between linagliptin (LNG) and tadalafil (TDL) in healthy males.Methods:First, a novel LC–MS method was developed; second, a Phase IV, open-label, cross-over study was performed. Volunteers took single 20-mg TDL dose on day 1 followed by wash out period of 2 weeks then multiple oral dosing of 5-mg/day LNG for 13 days. On day 13, volunteers were co-administered 20-mg TDL.Results:LNG and TDL single doses did not affect QTc interval. Smoking did not alter pharmacokinetics/pharmacodynamics of LNG and TDL. Co-administration of LNG with TDL resulted in TDL longer time to reach maximum plasma concentration (Tmax), decreased oral clearance (Cl/F) and oral volume of distribution (Vd/F), increased its maximum plasma concentration (Cmax), area under concentration-time curve (AUC), muscle pain and QTc prolongation.Conclusion:LNG and TDL co-administration warrants monitoring and/or TDL dose adjustment. Aim: Methods: Results: max max Conclusion.
Medienart: |
E-Artikel |
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Erscheinungsjahr: |
2019 |
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Erschienen: |
2019 |
Enthalten in: |
Zur Gesamtaufnahme - volume:11 |
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Enthalten in: |
Bioanalysis - 11(2019), 14, Seite 1321- |
Sprache: |
Englisch |
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Beteiligte Personen: |
Mourad, Sara S [VerfasserIn] |
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Links: |
FID Access [lizenzpflichtig] |
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Umfang: |
1 Online-Ressource (16 p) |
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doi: |
10.4155/bio-2018-0097 |
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funding: |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
KFL001038974 |
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520 | |a Aim:Assessment of pharmacokinetic interaction between linagliptin (LNG) and tadalafil (TDL) in healthy males.Methods:First, a novel LC–MS method was developed; second, a Phase IV, open-label, cross-over study was performed. Volunteers took single 20-mg TDL dose on day 1 followed by wash out period of 2 weeks then multiple oral dosing of 5-mg/day LNG for 13 days. On day 13, volunteers were co-administered 20-mg TDL.Results:LNG and TDL single doses did not affect QTc interval. Smoking did not alter pharmacokinetics/pharmacodynamics of LNG and TDL. Co-administration of LNG with TDL resulted in TDL longer time to reach maximum plasma concentration (Tmax), decreased oral clearance (Cl/F) and oral volume of distribution (Vd/F), increased its maximum plasma concentration (Cmax), area under concentration-time curve (AUC), muscle pain and QTc prolongation.Conclusion:LNG and TDL co-administration warrants monitoring and/or TDL dose adjustment. Aim: Methods: Results: max max Conclusion | ||
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