Population pharmacokinetics of tigecycline in healthy volunteers.
J Clin Pharmacol
; 47(6): 727-37, 2007 Jun.
Article
in En
| MEDLINE
| ID: mdl-17519399
ABSTRACT
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 AUC(0-12). This modeling supported phase II/III population pharmacokinetic model development to further determine individual patient tigecycline exposures for safety and efficacy analyses.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Minocycline
/
Anti-Bacterial Agents
Type of study:
Clinical_trials
/
Prognostic_studies
/
Systematic_reviews
Limits:
Adolescent
/
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
J Clin Pharmacol
Year:
2007
Document type:
Article