-
Je něco špatně v tomto záznamu ?
Bioequivalence study of two formulations of itraconazole 100 mg capsules in healthy volunteers under fed conditions: a randomized, three-period, reference-replicated, crossover study
V. Dragojević-Simić, A. Kovačević, V. Jaćević, N. Rančić, S. Djordjević, V. Kilibarda, M. Mikov, D. Bokonjić,
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu srovnávací studie, časopisecké články, randomizované kontrolované studie
- MeSH
- antifungální látky aplikace a dávkování farmakokinetika MeSH
- aplikace orální MeSH
- dospělí MeSH
- itrakonazol aplikace a dávkování analogy a deriváty farmakokinetika MeSH
- klinické křížové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- plocha pod křivkou MeSH
- poločas MeSH
- terapeutická ekvivalence MeSH
- tobolky MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
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 AUC0-72h, AUC0-∝, Cmax, Tmax, T1/2 and Kel. 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 AUC0-72h. Since the coefficient of variation (CV) for the reference product was 44.95% for Cmax, 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.
Citace poskytuje Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc18033003
- 003
- CZ-PrNML
- 005
- 20181024155553.0
- 007
- ta
- 008
- 181008s2018 enk f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1080/17425255.2018.1503649 $2 doi
- 035 __
- $a (PubMed)30028640
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a enk
- 100 1_
- $a Dragojević-Simić, Viktorija $u a Centre for Clinical Pharmacology , Military Medical Academy , Belgrade , Serbia. b Medical Faculty of the Military Medical Academy , University of Defense in Belgrade , Belgrade , Serbia.
- 245 10
- $a Bioequivalence study of two formulations of itraconazole 100 mg capsules in healthy volunteers under fed conditions: a randomized, three-period, reference-replicated, crossover study / $c V. Dragojević-Simić, A. Kovačević, V. Jaćević, N. Rančić, S. Djordjević, V. Kilibarda, M. Mikov, D. Bokonjić,
- 520 9_
- $a 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 AUC0-72h, AUC0-∝, Cmax, Tmax, T1/2 and Kel. 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 AUC0-72h. Since the coefficient of variation (CV) for the reference product was 44.95% for Cmax, 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.
- 650 _2
- $a aplikace orální $7 D000284
- 650 _2
- $a dospělí $7 D000328
- 650 _2
- $a antifungální látky $x aplikace a dávkování $x farmakokinetika $7 D000935
- 650 _2
- $a plocha pod křivkou $7 D019540
- 650 _2
- $a tobolky $7 D002214
- 650 _2
- $a klinické křížové studie $7 D018592
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a poločas $7 D006207
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a itrakonazol $x aplikace a dávkování $x analogy a deriváty $x farmakokinetika $7 D017964
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a terapeutická ekvivalence $7 D013810
- 650 _2
- $a mladý dospělý $7 D055815
- 655 _2
- $a srovnávací studie $7 D003160
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a randomizované kontrolované studie $7 D016449
- 700 1_
- $a Kovačević, Aleksandra $u a Centre for Clinical Pharmacology , Military Medical Academy , Belgrade , Serbia. b Medical Faculty of the Military Medical Academy , University of Defense in Belgrade , Belgrade , Serbia.
- 700 1_
- $a Jaćević, Vesna $u b Medical Faculty of the Military Medical Academy , University of Defense in Belgrade , Belgrade , Serbia. c National Poison Control Centre , Military Medical Academy , Belgrade , Serbia. d Department of Chemistry, Faculty of Science , University of Hradec Kralove , Hradec Kralove , Czech Republic.
- 700 1_
- $a Rančić, Nemanja $u a Centre for Clinical Pharmacology , Military Medical Academy , Belgrade , Serbia. b Medical Faculty of the Military Medical Academy , University of Defense in Belgrade , Belgrade , Serbia.
- 700 1_
- $a Djordjević, Snežana $u b Medical Faculty of the Military Medical Academy , University of Defense in Belgrade , Belgrade , Serbia. c National Poison Control Centre , Military Medical Academy , Belgrade , Serbia.
- 700 1_
- $a Kilibarda, Vesna $u b Medical Faculty of the Military Medical Academy , University of Defense in Belgrade , Belgrade , Serbia. c National Poison Control Centre , Military Medical Academy , Belgrade , Serbia.
- 700 1_
- $a Mikov, Momir $u e Institute for Pharmacology, Clinical Pharmacology and Toxicology , University of Novi Sad, Faculty of Medicine , Novi Sad , Serbia.
- 700 1_
- $a Bokonjić, Dubravko $u b Medical Faculty of the Military Medical Academy , University of Defense in Belgrade , Belgrade , Serbia.
- 773 0_
- $w MED00183846 $t Expert opinion on drug metabolism & toxicology $x 1744-7607 $g Roč. 14, č. 9 (2018), s. 979-988
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/30028640 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y a $z 0
- 990 __
- $a 20181008 $b ABA008
- 991 __
- $a 20181024160102 $b ABA008
- 999 __
- $a ok $b bmc $g 1339979 $s 1029997
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2018 $b 14 $c 9 $d 979-988 $e 20180801 $i 1744-7607 $m Expert opinion on drug metabolism & toxicology $n Expert Opin Drug Metab Toxicol $x MED00183846
- LZP __
- $a Pubmed-20181008
