Literature DB >> 18479176

Comparative bioavailability of lornoxicam as single doses of quick-release tablet, standard tablet and intramuscular injection: a randomized, open-label, crossover phase I study in healthy volunteers.

Susanna Radhofer-Welte1, Peter Dittrich, Marija Simin, Poul Erik Branebjerg.   

Abstract

BACKGROUND AND
OBJECTIVE: Lornoxicam is an NSAID used to obtain short-term relief of acute mild to moderate pain and symptomatic relief of pain and inflammation in rheumatoid arthritis and osteoarthritis. The aim of this study was to compare and evaluate the pharmacokinetic parameters of lornoxicam 8 mg as quick-release (QR) tablet, standard tablet (ST) and intramuscular injection (IM).
METHODS: Eighteen healthy volunteers (9 male, 9 female; average age 26.9 (SD 3.0) years; average body mass index 21.8 (SD 2.3) kg/m2 were randomized to three different treatment groups. Subjects received a single 8-mg dose of each lornoxicam formulation in a three-way crossover design on days 1, 8 and 15. Lornoxicam plasma concentrations were obtained from baseline to 24 hours using high-pressure liquid chromatography. The pharmacokinetic parameters area under the plasma concentration-time curve from zero to infinity (AUCinfinity), maximum plasma concentration (Cmax), time to maximum plasma concentration (tmax), terminal half-life (t1/2)) and mean residence time (MRT) were calculated.
RESULTS: Lornoxicam-QR was comparable with lornoxicam-ST and lornoxicam-IM regarding AUCinfinity, t1/2 and MRT. The AUCinfinity ratio (90% CI) was 1.07 (0.94, 1.20) for lornoxicam-QR/lornoxicam-ST and 1.10 (0.97, 1.24) for lornoxicam-QR/lornoxicam-IM. Cmax and tmax did not differ between lornoxicam-QR and lornoxicam-IM (p=0.66 and 0.07, respectively). Both lornoxicam-QR and lornoxicam-IM showed significantly shorter tmax and significantly higher Cmax values than lornoxicam-ST.
CONCLUSION: Lornoxicam-QR and lornoxicam-IM did not differ with respect to AUCinfinity, Cmax and tmax, but both lornoxicam-QR and lornoxicam-IM showed significantly shorter tmax and significantly higher Cmax values than lornoxicam-ST.

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Year:  2008        PMID: 18479176     DOI: 10.2165/00044011-200828060-00002

Source DB:  PubMed          Journal:  Clin Drug Investig        ISSN: 1173-2563            Impact factor:   2.859


  10 in total

1.  Role of CYP2C9 and its variants (CYP2C9*3 and CYP2C9*13) in the metabolism of lornoxicam in humans.

Authors:  Yingjie Guo; Yifan Zhang; Ying Wang; Xiaoyan Chen; Dayong Si; Dafang Zhong; J Paul Fawcett; Hui Zhou
Journal:  Drug Metab Dispos       Date:  2005-03-11       Impact factor: 3.922

2.  Role of human liver microsomal CYP2C9 in the biotransformation of lornoxicam.

Authors:  P Bonnabry; T Leemann; P Dayer
Journal:  Eur J Clin Pharmacol       Date:  1996       Impact factor: 2.953

3.  Determination of the novel non-steroidal anti-inflammatory drug lornoxicam and its main metabolite in plasma and synovial fluid.

Authors:  S Radhofer-Welte; P Dittrich
Journal:  J Chromatogr B Biomed Sci Appl       Date:  1998-04-10

4.  A multicenter, randomized, double blind study comparing lornoxicam with diclofenac in osteoarthritis.

Authors:  B Kidd; W Frenzel
Journal:  J Rheumatol       Date:  1996-09       Impact factor: 4.666

5.  A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability.

Authors:  D J Schuirmann
Journal:  J Pharmacokinet Biopharm       Date:  1987-12

6.  Analgesic efficacy and safety of lornoxicam quick-release formulation compared with diclofenac potassium: randomised, double-blind trial in acute low back pain.

Authors:  N Yakhno; A Guekht; A Skoromets; N Spirin; E Strachunskaya; A Ternavsky; K J Olsen; P L Moller
Journal:  Clin Drug Investig       Date:  2006       Impact factor: 2.859

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Authors:  G Hitzenberger; S Radhofer-Welte; F Takacs; D Rosenow
Journal:  Postgrad Med J       Date:  1990       Impact factor: 2.401

8.  Identification of a novel variant CYP2C9 allele in Chinese.

Authors:  Dayong Si; Yingjie Guo; Yifan Zhang; Lei Yang; Hui Zhou; Dafang Zhong
Journal:  Pharmacogenetics       Date:  2004-07

9.  Liquid chromatography-electrospray ionization tandem mass spectrometric determination of lornoxicam in human plasma.

Authors:  Young Hoon Kim; Hye Young Ji; Eun-Seok Park; Soo-Wan Chae; Hye Suk Lee
Journal:  Arch Pharm Res       Date:  2007-07       Impact factor: 4.946

Review 10.  Clinical pharmacokinetics of lornoxicam. A short half-life oxicam.

Authors:  N M Skjodt; N M Davies
Journal:  Clin Pharmacokinet       Date:  1998-06       Impact factor: 6.447

  10 in total
  3 in total

1.  Analgesic efficacy of quick-release versus standard lornoxicam for pain after third molar surgery: a randomized, double-blind, placebo-controlled, single-dose trial.

Authors:  Philip L Møller; Sven E Nørholt
Journal:  Clin Drug Investig       Date:  2008       Impact factor: 2.859

Review 2.  Pharmacokinetics, safety and efficacy of intra-articular non-steroidal anti-inflammatory drug injections for the treatment of osteoarthritis: A narrative review.

Authors:  Daniel J Selig; Adrian T Kress; Isaiah M Horton; Jeffrey R Livezey; Eliot J Sadik; Jesse P DeLuca
Journal:  J Clin Pharm Ther       Date:  2022-05-03       Impact factor: 2.145

3.  Sciatic nerve injury following analgesic drug injection in rats: A histopathological examination.

Authors:  Habib Bostan; Murat Cabalar; Serdar Altinay; Yildiray Kalkan; Levent Tumkaya; Ayhan Kanat; Sabri Balik; Adem Erkut; Dudu Altuner; Ziya Salihoglu; Abdulkadir Kocer
Journal:  North Clin Istanb       Date:  2018-09
  3 in total

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