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Original Paper
Pharmacokinetics and dose proportionality of three Tramadol Contramid® OAD tablet strengths
Article first published online: 18 JUN 2007
DOI: 10.1002/bdd.561
Copyright © 2007 John Wiley & Sons, Ltd.
1099-081X/asset/cover.gif?v=1&s=775b0464937511d06451e5bae72dfa31ddb4dca8 "Biopharmaceutics & Drug Disposition")
Additional Information
How to Cite
Karhu, D., El-Jammal, A., Dupain, T., Gaulin, D. and Bouchard, S. (2007), Pharmacokinetics and dose proportionality of three Tramadol Contramid® OAD tablet strengths. Biopharm. Drug Dispos., 28: 323–330. doi: 10.1002/bdd.561
Publication History
- Issue published online: 18 JUN 2007
- Article first published online: 18 JUN 2007
- Manuscript Accepted: 4 MAR 2007
- Manuscript Revised: 1 MAR 2007
- Manuscript Received: 27 SEP 2006
Funded by
- Labopharm Inc., Canada
- Abstract
- References
- Cited By
Keywords:
- tramadol;
- controlled-release;
- dose proportionality;
- pharmacokinetics
Abstract
A three-way crossover study in 27 human volunteers was conducted to characterize the pharmacokinetics and to assess the dose proportionality of 100 mg, 200 mg and 300 mg strengths of a novel once-a-day tramadol controlled-release tablet (Tramadol Contramid® OAD) following single-dose administration. Serial blood samples were collected at predefined timepoints over a 48 h period and racemic tramadol and O-desmethyltramadol concentrations in plasma were determined using a validated LC-MS/MS method. Pharmacokinetic parameters were derived using noncompartmental methods. Following dose normalization and logarithmic transformation of concentration-dependent parameters, the results were compared using analysis of variance (ANOVA). The residual variability thereby obtained was used to construct 90% classical confidence intervals. The two one-sided tests procedure was used for all pairwise comparisons. Dose proportionality was concluded since the 90% CI for the ratio of geometric means was included in the acceptance range of 0.80–1.25 for all comparisons. Copyright © 2007 John Wiley & Sons, Ltd.