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Részletek

A cikk állandó MOB linkje:
http://mob.gyemszi.hu/detailsperm.jsp?PERMID=153654
MOB:2022/1
Szerzők:Hincal, A. Atilla; Özseven, Cemre; Meer, Mike van der; Erenmemisoglu, Aydin; Bilgic, Mahmut; Martin, Wolfgang
Tárgyszavak:FÁJDALOMCSILLAPÍTÓK; BIOLÓGIAI HASZNOSÍTHATÓSÁG; FARMAKOKINETIKA
Folyóirat:Acta Pharmaceutica Hungarica - 2022. 92. évf. 1. sz.
[https://www.aph-hsps.hu/acta/index.php/aph/issue/archive]


  Relative bioavailability study of a generic effervescent tablet formulation of dexketoprofen and thiocolchicoside versus the originator 25 mg film coated tablet (dexketoprofen) and 8 mg capsule (thiocolchicoside) / A. Atilla Hincal [et al.]
  Bibliogr.: p. 51. - Abstr. eng. - DOI: https://doi.org/10.33892/aph.2022.92.45-51
  In: Acta Pharmaceutica Hungarica. - ISSN 0001-6659. - 2022. 92. évf. 1. sz., p. 45-51. : ill.


Aims: The aim of this study was to evaluate the pharmacokinetic profiles and the relative bioavailability of dexketoprofen and thiocolchicoside of the test preparation (dexketoprofen / thiocolchicoside 25 mg / 8 mg effervescent tablet) in comparison with the reference preparations (Keral 25 mg film coated tablet, containing dexketoprofen trometamol equivalent to 25 mg dexketoprofen (Menarini International Operations Luxembourg S.A.) (R1) and Muscoril 8 mg capsule, containing 8 mg thiocolchicoside (Sanofi Aventis Ilaçlari Ltd. Şti.) (R2) under fasting conditions. Methods: 25 healthy male subjects were enrolled in the study. Volunteers were hospitalised from the evening before drug administration (Day 0) until after the 24-hour blood sampling time on Day 2. Results: 24 subjects completed the study. Relative bioavailability (AUCT/AUCR1) of dexketoprofen from the test preparation was 100.99 %; (AUCT/AUCR2) of 3-O-glucuronide of thiocolchicoside (aglycone) from the test preparation was 100.47 %; (Cmax,T/Cmax,R1) of dexketoprofen from the test preparation was 122.59 %; (Cmax,T/Cmax,R2) of 3-O-glucuronide of thiocolchicoside (aglycone) from the test preparation was 111.43 %. Conclusions: The relative bioavailability AUCT /AUCR of the test preparation compared with both reference preparations is comparable, as shown by the geometric mean ratios of 100.59 % (dexketoprofen) and of 98.20 % (3-O-glucuronide of thiocolchicoside (aglycone). Kulcsszavak: Dexketoprofen, Thiocolchicoside, Relative bioavailability study