Fasting and FED bioequivalence studies of etodolac sustained release tablets manufactured in Turkey in healthy volunteers Türkiye’de üretilen etodolak içeren uzatilmiş salimli tabletlerin sağlikli gönüllülerde açlik ve tokluk koşullarinda yapilan biyoeşdeğerlik çalişmalari

Uslu A., Dikmen İ., Ünsalan S., Kılınç B., Sağlam O., Erenmemişoğlu A., ...More

Nobel Medicus, vol.12, no.2, pp.53-59, 2016 (Scopus) identifier

  • Publication Type: Article / Article
  • Volume: 12 Issue: 2
  • Publication Date: 2016
  • Journal Name: Nobel Medicus
  • Journal Indexes: Scopus
  • Page Numbers: pp.53-59
  • Keywords: Bioequivalence, Etodolac, Pain, Sustained release (SR) tablet
  • Istanbul Medipol University Affiliated: No


Objective: The current study was designed to compare the pharmacokinetic properties and tolerability of the newly developed sustained release (SR) tablet of etodolac 600 mg (NOBEL ILAC, Turkey), with those of the conventional tablet of the marketed innovator formulation, Lodine SR tablet, 600 mg from Almirall Ltd, England, administrated into healthy male subjects in fasting and fed conditions. Material and Method: Both fasting study and fed study were a single centre, open-label, randomised, single oral dose, cross-over, two sequence, two-period study. 36 subjects were randomly assigned into 2 groups according to a computer-generated randomization scheme. The subjects in group 1 received the reference formulation in Period 1 and the test formulation in Period 2, and those in group 2 vice versa, with a 7 day washout period between Periods 1 and 2. Totally 21 blood sample points were selected including predose. The determination of etodolac was performed using a validated high performance liquid chromatography occupied with UV (HPLC-UV) in lithium heparinised human plasma. Results: Pharmacokinetic findings showed that the newly developed SR tablet of NOBEL ILAC was bioequivalent to the marketed innovator formulation in healthy population under fasting and fed conditions. Conclusions: Results indicated that the new SR formulation of NOBEL ILAC can be used interchangeably with the formulation of the innovator.