Bioequivalence study of two formulations of itraconazole 100 mg capsules in healthy volunteers under fed conditions: a randomized, three-period, reference-replicated, crossover study
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62690094%3A18470%2F18%3A50014831" target="_blank" >RIV/62690094:18470/18:50014831 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.1080/17425255.2018.1503649" target="_blank" >http://dx.doi.org/10.1080/17425255.2018.1503649</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1080/17425255.2018.1503649" target="_blank" >10.1080/17425255.2018.1503649</a>
Alternative languages
Result language
angličtina
Original language name
Bioequivalence study of two formulations of itraconazole 100 mg capsules in healthy volunteers under fed conditions: a randomized, three-period, reference-replicated, crossover study
Original language description
Background: The aim of the study was to evaluate the bioequivalence of two itraconazole 100 mg capsule formulations. Research design and methods: The single-center, open-label, randomized, three-period, three-sequence, reference-replicated, cross-over study included 38 healthy subjects under fed conditions. In each study period (separated by a 14-day washout), a single oral dose of the test (T) or reference (R) product was administered. Blood samples were collected at pre-dose and up to 72.0 h after administration. The calculated pharmacokinetic parameters, based on the plasma concentrations of itraconazole and hydroxy itraconazole, were AUC(0-72h), AUC(0-proportional to), C-max, T-max, T-1/2 and K-el. Results: The 90% CI for the test/reference geometric means ratio for the parent compound, itraconazole, was in the range from 85.29% to 116.07% for AUC(0-72h.) Since the coefficient of variation (CV) for the reference product was 44.95% for C-max, the 90% CI for this parameter for itraconazole was 93.49-133.78%, which was within the proposed limits of the EMA for bioequivalence of 72.15-138.59%. During the study, 4 subjects encountered a total of 14 mild adverse events. Conclusions: The use of the reference-scaling approach with 3-period design (TRR, RTR, and RRT) was an efficient way to demonstrate that two commercially available oral itraconazole formulations met the predetermined bioequivalence criteria.
Czech name
—
Czech description
—
Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
—
OECD FORD branch
30104 - Pharmacology and pharmacy
Result continuities
Project
—
Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2018
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY
ISSN
1742-5255
e-ISSN
—
Volume of the periodical
14
Issue of the periodical within the volume
9
Country of publishing house
GB - UNITED KINGDOM
Number of pages
10
Pages from-to
979-988
UT code for WoS article
000444089500011
EID of the result in the Scopus database
2-s2.0-85052146917