RESEARCH ARTICLE
Nobel Med 2016; 12(2): 53-59
FASTING AND FED BIOEQUIVALENCE STUDIES OF ETODOLAC SUSTAINED RELEASE TABLETS MANUFACTURED IN TURKEY IN HEALTHY VOLUNTEERS
Abdullah Uslu, İlksen Dikmen, Seda Ünsalan, Berrak Kılınç, Onursal Sağlam, Aydın Erenmemişoğlu, İclal Çakıcı, Ömer OcakABSTRACT
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.
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Pubmed Style
Abdullah Uslu, İlksen Dikmen, Seda Ünsalan, Berrak Kılınç, Onursal Sağlam, Aydın Erenmemişoğlu, İclal Çakıcı, Ömer Ocak. [FASTING AND FED BIOEQUIVALENCE STUDIES OF ETODOLAC SUSTAINED RELEASE TABLETS MANUFACTURED IN TURKEY IN HEALTHY VOLUNTEERS]. Nobel Med 2016; 12(2): 53-59, English. -
Web Style
Abdullah Uslu, İlksen Dikmen, Seda Ünsalan, Berrak Kılınç, Onursal Sağlam, Aydın Erenmemişoğlu, İclal Çakıcı, Ömer Ocak. [FASTING AND FED BIOEQUIVALENCE STUDIES OF ETODOLAC SUSTAINED RELEASE TABLETS MANUFACTURED IN TURKEY IN HEALTHY VOLUNTEERS]. www.nobelmedicus.com/en/Article.aspx?m=1716 [Access: Mayıs 24, 2021], English. -
AMA (American Medical Association) Style
Abdullah Uslu, İlksen Dikmen, Seda Ünsalan, Berrak Kılınç, Onursal Sağlam, Aydın Erenmemişoğlu, İclal Çakıcı, Ömer Ocak. [FASTING AND FED BIOEQUIVALENCE STUDIES OF ETODOLAC SUSTAINED RELEASE TABLETS MANUFACTURED IN TURKEY IN HEALTHY VOLUNTEERS]. Nobel Med 2016; 12(2): 53-59, English. -
Vancouver/ICMJE Style
Abdullah Uslu, İlksen Dikmen, Seda Ünsalan, Berrak Kılınç, Onursal Sağlam, Aydın Erenmemişoğlu, İclal Çakıcı, Ömer Ocak. [FASTING AND FED BIOEQUIVALENCE STUDIES OF ETODOLAC SUSTAINED RELEASE TABLETS MANUFACTURED IN TURKEY IN HEALTHY VOLUNTEERS]. Nobel Med (2016); 12(2): 53-59, [cited Mayıs 24, 2021], English. -
Harvard Style
Abdullah Uslu, İlksen Dikmen, Seda Ünsalan, Berrak Kılınç, Onursal Sağlam, Aydın Erenmemişoğlu, İclal Çakıcı, Ömer Ocak. (2016) [FASTING AND FED BIOEQUIVALENCE STUDIES OF ETODOLAC SUSTAINED RELEASE TABLETS MANUFACTURED IN TURKEY IN HEALTHY VOLUNTEERS]. Nobel Med, 12(2): 53-59, English.