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Open‑label, randomized, single‑dose, crossover study to evaluate the pharmacokinetics and safety differences between two docetaxel products, CKD‑810 and Taxotere injection, in patients with advanced solid cancer

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Author(s)
Eun Kyung ChoJi‑Young ParkKyung Hee LeeHong Suk SongYoung Joo MinYeul Hong KimJin‑Hyoung Kang
Keimyung Author(s)
Song, Hong Suk
Department
Dept. of Internal Medicine (내과학)
Journal Title
Cancer Chemotherapy and Pharmacology
Issued Date
2014
Volume
73
Issue
1
Abstract
Purpose : The aim of this study was to compare CKD-810 (test docetaxel) with Taxotere® (reference docetaxel) in terms of pharmacokinetics and safety for patients with advanced or metastatic carcinoma.
Methods : A randomized, open-label, two-way crossover study was conducted in eligible patients. Patients received with reference or test drugs of 75 mg/m2 docetaxel by intravenous infusion for 60 min in the first period and the alternative drug in the second period with a washout of 3 weeks. Plasma concentrations of docetaxel were determined by validated high-performance liquid chromatography coupled to tandem mass spectrometry detection. Pharmacokinetic parameters, including the maximum plasma concentration (C max) and the area under the concentration–time curve (AUC), were determined by non-compartmental analysis.
Results : A total of 44 patients were included in the study, 21 patients received test drug and 23 received reference drug for the first cycle. The C max of docetaxel was 2,658.77 ng/mL for test drug and 2,827.60 ng/mL for reference drug, and two drugs showed no difference with a statistical significance. Time to reach C max (T max) of CKD-810 (0.94 h) versus reference docetaxel (0.97 h) was also not significantly different. Other pharmacokinetic parameters including the plasma AUC, elimination half-life, and total body clearance exhibited similar values without a significant difference. The most common grade 3 or 4 toxicity was neutropenia (CKD-810 19.5 or 29.3 %; reference docetaxel 14.6 or 41.5 %). Febrile neutropenia was experienced by only one patient in each group. Two patients died of progression of disease during the study.
Conclusion : Docetaxel anhydrous CKD-810 use with patients suffering advanced or metastatic solid malignancies was equivalent to reference docetaxel in terms of pharmacokinetic parameters and safety profile. Additionally, the test and reference drug met the regulatory criteria for pharmacokinetic equivalence.
Keywords : Docetaxel – CKD-810 – Pharmacokinetics – Polysorbate
Keimyung Author(s)(Kor)
송홍석
Publisher
School of Medicine
Citation
Eun Kyung Cho et al. (2014). Open‑label, randomized, single‑dose, crossover study to evaluate the pharmacokinetics and safety differences between two docetaxel products, CKD‑810 and Taxotere injection, in patients with advanced solid cancer. Cancer Chemotherapy and Pharmacology, 73(1), 9–16. doi: 10.1007/s00280-013-2264-0
Type
Article
ISSN
0344-5704
Source
http://lps3.link.springer.com.proxy.dsmc.or.kr/article/10.1007%2Fs00280-013-2264-0
DOI
10.1007/s00280-013-2264-0
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/35297
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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