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Effects of Yogurt and Applesauce on the Oral Bioavailability of Nilotinib in Healthy Volunteers.
- Source :
- Journal of Clinical Pharmacology; Nov2011, Vol. 51 Issue 11, p1580-1586, 7p
- Publication Year :
- 2011
-
Abstract
- Nilotinib, a potent orally bioavailable BCR-ABL tyrosine kinase inhibitor, is currently available as a hard gelatin capsule that must be swallowed whole. For patients who may have difficulty swallowing the intact capsule, an alternative mode of administration is desirable. The authors compared the bioavailability of nilotinib from the following administrations in 48 healthy subjects: (1) 400 mg nilotinib given as two 200-mg nilotinib intact capsules; (2) contents of two 200-mg nilotinib capsules, each capsule dispersed in 1 teaspoon of nonfat plain yogurt; and (3) contents of two 200-mg nilotinib capsules, each capsule dispersed in 1 teaspoon of applesauce. Nilotinib absorption was modestly increased following the administration of nilotinib dispersed in yogurt. The geometric mean ratios (90% confidence intervals) for nilotinib Cmax, AUC0-tlast, and AUC0-inf were 1.31 (1.22-1.41), 1.11 (1.05-1.16), and 1.08 (1.02-1.15), respectively. Administration of nilotinib dispersed in applesauce showed equivalent bioavailability compared with administration of nilotinib as intact capsules. The geometric mean ratios (90% confidence intervals) for nilotinib Cmax, AUC0-tlast, and AUC0-inf were 0.95 (0.88-1.02), 0.99 (0.94-1.04), and 0.97 (0.90-1.03), respectively. Each treatment was well tolerated in the study subjects. The data support a feasible alternative method of nilotinib administration; each capsuleās contents may be dispersed in 1 teaspoon of applesauce and taken immediately. [ABSTRACT FROM PUBLISHER]
- Subjects :
- TREATMENT effectiveness
CHRONIC myeloid leukemia
TRANSFERASES
STATISTICAL sampling
RESEARCH funding
REGRESSION analysis
HEALTH outcome assessment
ORAL drug administration
MASS spectrometry
LIQUID chromatography
ENZYME inhibitors
DRUG-food interactions
DEGLUTITION disorders
CROSSOVER trials
CONFIDENCE intervals
BIOLOGICAL assay
BIOAVAILABILITY
APPLES
ANALYSIS of variance
YOGURT
THERAPEUTICS
Subjects
Details
- Language :
- English
- ISSN :
- 00912700
- Volume :
- 51
- Issue :
- 11
- Database :
- Complementary Index
- Journal :
- Journal of Clinical Pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 66697955
- Full Text :
- https://doi.org/10.1177/0091270010384116