Lack of effect of colesevelam HCl on the single-dose pharmacokinetics of aspirin, atenolol, enalapril, phenytoin, rosiglitazone, and sitagliptin
| Autor: | James Lee, Jeanne Mendell-Harary, Prachi Wickremasingha, Ben Tao, Joseph R. Walker, Ling He, Douglas Wight |
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| Rok vydání: | 2013 |
| Předmět: |
Phenytoin
Adult Male Adolescent Endocrinology Diabetes and Metabolism Colesevelam Hydrochloride Pharmacology Allylamine Rosiglitazone Young Adult Endocrinology Pharmacokinetics Enalapril Internal Medicine medicine Humans Hypoglycemic Agents Drug Interactions Tissue Distribution Antihypertensive Agents Aspirin Dose-Response Relationship Drug business.industry Colesevelam Anticholesteremic Agents Anti-Inflammatory Agents Non-Steroidal Sitagliptin Phosphate General Medicine Middle Aged Triazoles Atenolol Crossover study Sitagliptin Area Under Curve Pyrazines Anticonvulsants Female Thiazolidinediones business medicine.drug |
| Zdroj: | Diabetes research and clinical practice. 104(3) |
| ISSN: | 1872-8227 |
| Popis: | Aims Drug interactions with bile acid sequestrants are primarily due to the potential of these agents to bind to concomitant drugs. Six clinical studies were performed to determine the effects of colesevelam on the pharmacokinetics of aspirin, atenolol, enalapril, phenytoin, rosiglitazone, and sitagliptin. Methods All six studies enrolled healthy subjects aged 18–45 years. The phenytoin study used a single-dose, three-period crossover design (phenytoin alone, phenytoin simultaneously with colesevelam, and phenytoin 4h before colesevelam). The other studies used a two-period crossover design (test drug alone and test drug simultaneously with colesevelam). Colesevelam (3750mg once daily) was dosed throughout the pharmacokinetic sampling period. After each single dose of the test drug, serial blood samples were collected for determination of plasma drug concentrations and calculation of pharmacokinetic parameters. Results For all six test drugs, 90% CIs for geometric least-squares mean ratios of AUC and C max for the measured analytes were within specified limits, indicating no interaction between the test drug and colesevelam. Conclusions Aspirin, atenolol, enalapril, rosiglitazone, and sitagliptin may be taken with colesevelam. Although the phenytoin study indicated no pharmacokinetic interaction, phenytoin should continue to be taken ≥4h before colesevelam in accordance with current prescribing information. |
| Databáze: | OpenAIRE |
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