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Arzneimittelforschung 2007; 57(8): 542-546
DOI: 10.1055/s-0031-1296646
Analgesics · Anti-inflammatories · Antiphlogistics · Antirheumatic Drugs
Editio Cantor Verlag Aulendorf (Germany)

Pharmacokinetics and Bioequivalence Study of Two Brands of Loxoprofen Tablets in Healthy Volunteers

Ok Hwa Jhee
1   Department of Practical Arts Education, Gongju National University of Education, Gongju-Si, Chungnam, South Korea
,
Min Ho Lee
2   Department of Internal Medicine, College of Medicine, Hanyang University, Seoul, South Korea
,
Leslie M. Shaw
3   Department of Pathology & Internal Medicine, University of Pennsylvania Medical Center, Philadelphia, PA, USA
,
Seo Eun Lee
4   Department of Physiology, College of Medicine, Hanyang University, Seoul, South Korea
,
Jin Hee Park
5   Department of Pharmacology & Institute of Biomedical Sciences, College of Medicine; Department of Bioengineering, College of Engineering, Hanyang University, Seoul, South Korea
,
Ju Seop Kang
5   Department of Pharmacology & Institute of Biomedical Sciences, College of Medicine; Department of Bioengineering, College of Engineering, Hanyang University, Seoul, South Korea
› Author Affiliations
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Publication History

Publication Date:
21 December 2011 (online)

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Abstract

The aims of this study were to assess the pharmacokinetics and bioequivalence of two brands of loxoprofen (CAS 80832-23-6) 60 mg tablets in healthy male volunteers. The several pharmacokinetic parameters were evaluated after an oral administration after an overnight fast according to a single dose, two-sequence, and cross-over randomized design with a 1-week washout interval. Serial blood samples were collected throughout 10 h after administration of the reference and test drug. Plasma was analyzed by validated HPLC with UV detection. Several pharmacoki-netic parameters, including AUCinfinity, AUCt, Cmax, Tmax, T1/2, and Ke were deter-mined from blood concentrations of both formulations. AUCt, AUCinfinity and Cmax were evaluated for bioequivalence after log-transformation of data using ANOVA with 90 % confidence interval level. The parametric 90 % confidence intervals of AUCt, AUCinfinity, and Cmax were 90.13– 106.34 %, 91.43–106.94 %, and 91.17– 108.53 %, respectively. All of the tested parameters were within the acceptable range of 80–125 %. Based on these statistical considerations, it was concluded that the test drug was bioequivalent to the reference drug.

Key words

Anti-infammatories, non-steroidal - CAS 80832-23-6 - Loxoprofen, bioequivalence, pharmacokinetics