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Lornoxicam Immediate‐Release Tablets: Formulation and Bioequivalence Study in Healthy Mediterranean Volunteers Using a Validated LC‐MS/MS Method
Author(s) -
Zaid Abdel Naser,
Mousa Ayman,
Jaradat Nidal,
Bustami Rana
Publication year - 2017
Publication title -
clinical pharmacology in drug development
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.711
H-Index - 22
eISSN - 2160-7648
pISSN - 2160-763X
DOI - 10.1002/cpdd.333
Subject(s) - bioequivalence , medicine , cmax , lornoxicam , pharmacokinetics , confidence interval , crossover study , dosing , interchangeability , pharmacology , chromatography , analgesic , placebo , chemistry , alternative medicine , pathology , computer science , programming language
This study aimed to demonstrate interchangeability between 2 lornoxicam tablet formulations under fasting conditions among Mediterranean Arabs by using a newly validated high‐pressure liquid chromatography–tandem mass spectrometry method. A single‐oral solid dosage form (8 mg/tablet), randomized, open‐label, 2‐way crossover study was conducted on 30 healthy male volunteers. Blood samples were collected prior to dosing and over a 24‐hour period, and the washout period was 9 days. Statistical comparison of the main pharmacokinetic parameters showed no significant difference between generic and branded products. The point estimates (ratios of geometric mean %) were 90.91, 96.34, and 94.86 for C max, AUC 0–last , and AUC 0–∞ , respectively. The 90% confidence intervals were within the predefined limits of 80.00%–125.00%, as specified by the international guidelines. This study showed that both formulations met the regulatory criteria for bioequivalence.