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The Bioequivalence of Telithromycin Administered Orally as Crushed Tablets Versus Tablets Swallowed Whole
Author(s) -
Lippert Christina,
Gbenado Seth,
Qiu Chunfu,
Lavin Bruce,
Kovacs Steven J.
Publication year - 2005
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270005279273
Subject(s) - bioequivalence , telithromycin , pharmacokinetics , crossover study , medicine , pharmacology , dosage form , chromatography , antibacterial agent , chemistry , antibiotics , biochemistry , alternative medicine , pathology , placebo
This open‐label, randomized, crossover study was conducted to demonstrate bioequivalence for telithromycin administered as crushed or whole tablets. Single 800‐mg telithromycin doses (2 × 400‐mg tablets) were administered as crushed tablets mixed in 240 mL nutritional supplement drink followed by 120 mL water or as whole tablets swallowed with 240 mL water. Plasma telithromycin concentrations were measured by liquid chromatography/mass spectrometry; pharmacokinetic parameters were determined using noncompartmental methods. Average bioequivalence criteria were applied. Thirty‐two subjects received telithromycin by both methods. The 90% confidence intervals for the geometric mean ratios of maximum plasma concentration and area under the plasma concentration‐time curve to 24 hours were within the 0.80 to 1.25 range. Median t max was 3.00 hours for both treatments. Both methods of administration were well tolerated. Crushing telithromycin tablets and administering them with a nutritional supplement drink is bioequivalent to ingesting whole tablets and could be a viable method of administration for patients unable to swallow tablets whole.