Details

Autor(en) / Beteiligte

• Van Wart, S. A.
• Cirincione, B. B.
• Ludwig, E. A.
• Meagher, A. K.
• Korth-Bradley, J. M.
• Owen, J. S.

Titel

Population Pharmacokinetics of Tigecycline in Healthy Volunteers

Ist Teil von

• Journal of clinical pharmacology, 2007-06, Vol.47 (6), p.727-737

Ort / Verlag

Oxford, UK: Blackwell Publishing Ltd

Erscheinungsjahr

2007

Quelle

MEDLINE

Beschreibungen/Notizen

• Tigecycline, a novel glycylcycline, possesses broad‐spectrum antimicrobial activity. A structural population pharmacokinetic model for tigecycline was developed based on data pooled from 5 phase I studies. Intravenous tigecycline was administered as single (12.5–300 mg) or multiple (25–100 mg) doses every 12 hours for up to 10 days. Three‐compartment models with zero‐order input and first‐order elimination separately described the single‐ or multiple‐dose full‐profile data. Additional models were evaluated using a subset of the phase I data mimicking the phase II/III trial sparse‐sampling scheme and dosage. A 2‐compartment model best described the reduced phase I data following single or multiple doses and provided reliably accurate estimates of tigecycline AUC0–12. This modeling supported phase II/III population pharmacokinetic model development to further determine individual patient tigecycline exposures for safety and efficacy analyses.