The Bioequivalence of Plunazol Tablet (Fluconazole 150 mg) to Three capsules of Diflucan 50 mg |
Chang, Hee-Chul
(Life Science Research Institute, Daewoong Pharm. Co. Ltd.)
Lee, Min-Suk (Life Science Research Institute, Daewoong Pharm. Co. Ltd.) Ryu, Chong-Hyon (Life Science Research Institute, Daewoong Pharm. Co. Ltd.) Lyu, Seung-Hyo (Life Science Research Institute, Daewoong Pharm. Co. Ltd.) Cho, Sang-Heon (Department of Clinical Pharmacology and Therapeutics, ASAN Medical Center) Choi, Yeon-Jin (Department of Clinical Pharmacology and Therapeutics, ASAN Medical Center) Hwang, Ae-Kyung (Department of Clinical Pharmacology and Therapeutics, ASAN Medical Center) Kim, Yun-Ah (Department of Clinical Pharmacology and Therapeutics, ASAN Medical Center) Park, Si-Hyun (Department of Clinical Pharmacology and Therapeutics, ASAN Medical Center) Yoon, Ji-Won (Department of Clinical Pharmacology and Therapeutics, ASAN Medical Center) Bae, Kyun-Seop (Department of Clinical Pharmacology and Therapeutics, ASAN Medical Center) |
1 | S. Jevons, L. Lees and M.H. Tarbit, Early clinical experience with UK-49,858 in human volunteers and patients. (abstract #S-64-3) 14th International Congress of Chemotherapy, Kyoto, 23-28, June (1985) |
2 | H. Washton, Review of fluconazole: a new triazole antifungal agent, Diagn. Microbiol. Infect. Dis. 12 (4 Suppl.), 229-233 (1989) DOI ScienceOn |
3 | M. Nakashima, The clinical study of fluconazole against pulmonary mycosis. Effects of fluconazole on pulmonary cryptococcosis and aspergillosis, and its pharmacokinetics in patients, Jpn. J. Antibiot. 42 (1), 127-137 (1989) DOI |
4 | Diflucan drug information. Pfizer. Available at: www.pfizer.com |
5 | S.M. Grant and S.P. Clissold, Fluconazole. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in superficial and systemic mycoses, Drugs, 39 (6), 877-916 (1990) DOI ScienceOn |
6 | 식품의약품안전청 고시 제 2005-31호, 생물학적동등성시험기준 (2005.6.7) |
7 | K. Shiba, A. Saito and T. Miyahara, Pharmacokinetic evaluation of fluconazole in healthy volunteers, Jpn. J. Antibiot., 42 (1),17-30 Jan (1989) |
8 | 식품의약품안전청 고시 제 1999-67호, 의약품임상시험관리기준 (2000.1.4) |
9 | R. Peireira, S. Fidelis, M.L. Vanunci, C.H. Oliveira, G.D. Mendes, E. Abib and R.A. Moreno, Bioequivalence study of two Fluconazole capsule formulations in healthy volunteers. Int. J. Clin. Pharmacol. & Ther., 42 (1), 39-42 (2004) |
10 | L.A. Moraes, F.E. Lerner, M.E. Moraes, M.O. Moraes, G. Corso and G. De Nucci, Fluconazole Bioequivalence Study:Quantification by Tandem Mass Spectroscopy. Ther Drug Monit., 21, 200-207 (1999) DOI ScienceOn |
11 | M.G. Rinaldi, P.A. Robinson, J.R. Graybill, J.J. Stern and A.M. Sugar, Fluconazole concentrations in patients undergoing antifungal therapy. 28th ICAAC, Los Angeles, abstract no.66, pp. 23-26, Oct. (1988) |