Bioequivalence of Pinatos Capsule 10 mg to Ketas Capsule 10 mg (Ibudilast 10 mg)
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Kang, Hyun-Ah
(Pharmaceutical Research Institute, CJ Cheiljedang Corp.)
Kim, Se-Mi (Research Institute, ChongKunDang Pharm.) Kang, Min-Sun (Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University) Yoo, Dong-Jin (Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University) Lee, Sang-No (Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University) Kwon, In-Ho (Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University) Yoo, Hee-Doo (Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University) Lee, Yong-Bok (Institute of Bioequivalence and Bridging Study, College of Pharmacy, Chonnam National University) |
1 | Y.J. Lee, Y.G. Kim, M.G. Lee, S.J. Chung, M.H. Lee and C.K. Shim, Analysis of bioequivalence study using logtransformed model, Yakhakhoeji, 44, 308-314 (2000). |
2 | KFDA, Guideline for Korean Good Clinical Practice (2007). |
3 | Dae Jung Pharm. Co., Ltd, Report of bioequivalence of Pinatos Capsule (Ibudilast 10 mg) (1995). |
4 | H. Yoon, H.Y. Cho and Y.B. Lee, Determination of ibudilast in human serum by high-performance liquid chromatography, Biomed. Chromatogr., 24(3), 324-328 (2010). |
5 | Food and Drug Administration (FDA): Guidance for Industry; Waiver of in vivo bioavailability and bioequivalence study for immediate-release solid oral dosage forms based on a biopharmaceutics classification system, Center for Drug Evaluation and Research (CDER) (2000). |
6 | L.C. Gibson, S.F. Hastings, I. McPhee, R.A. Clayton, C.E. Darroch, A. Mackenzie, F.L. Mackenzie, M. Nagasawa, P. A. Stevens and S.J. Mackenzie, The inhibitory profile of ibudilast against the human phosphodiesterase enzyme family, Eur. J. Pharmacol., 538, 39-42 (2006). DOI |
7 | S. Maeda, R. Ishida, M. Komuro, S. Ohmuro, H. Hashimoto, M. Hotta and H. Uchida, Studies of KC-404 (3-isobutyryl-2- isopopylpyrazolo-[1,5-apyridine]) pharmacokinetics in humans (Report 2), Clinical Report (Kiso to Rinsho), 23, 183-189 (1989). |
8 | K. Nishino, S. Hara and T. Irikura, Effect of KC-404 on allergic reactions type I-IV, Nippon Yakurigaku Zasshi, 83, 291-299 (1984). DOI ScienceOn |
9 | P. Rolan, J.A. Gibbons, L. He, E. Chang, D. Jones, M.I. Gross, J.B. Davidson, L.M. Sanftner and K.W. Johnson, Ibudilast in healthy volunteers: safety, tolerability and pharmacokinetics with single and multiple doses, Br. J. Clin. Pharmacol., 66, 792-801 (2008). DOI |
10 | T. Li, Y. Pang, Z. Wang, Y. Jia, Q. Cheng and J. Sun, Pharmacokinetics and relative bioavailability of KC-404 sustained release tablets in healthy volunteers, Sichuan Da Xue Xue Bao. Yi Xue Ban, 34, 541-543 (2003). |
11 | KFDA, Guideline for Bioequivalence Test (2005). |
12 | K.Y. Chang, S.W. Kang, E.J. Yoo, S.H. Lew, K.R. Lee and H.J. Lee, Bioequivalence of dilast capsule to ketas capsule (ibudilast 10 mg), J. Kor. Pharm. Sci., 37(3), 197-203, 2007. |
13 |
Statistical Solutions Ltd., Equiv |
14 | K. Nishino, H. Ohkubo, M. Ohashi, S. Hara, J. Kito and T. Irikura, KC-404: a potential anti-allergic agent with antagonistic action against slow reacting substance of anaphylaxis, Japan. J. Pharmacol., 33, 267-278 (1983). DOI |
15 | Y. Kishi, S. Ohta, N. Kasuya, S. Sakita, T. Ashikaga and M. Isobe, Ibudilast: a non-selective PDE inhibitor with multiple actions on blood cells and the vascular wall, Cardiovasc. Drug Rev., 19, 215-225 (2001). |
16 | M. Ohashi, Y. Kudo, Y. Ichikawa and K. Nishino, Antithrombotic effect of KC-404, a novel cerebral vasodilator, Gen. Pharmacol., 17, 385-389 (1986). DOI ScienceOn |
17 | H. Fukuyama, J. Kimura, H. Yamauchi, M. Ogawa, T. Doi, Y. yonekura and J. Konishi, Pharmacological effects of ibudilast on cerebral circulation: a PET study, Neurol. Res., 15, 169-173 (1993). DOI |
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