Journal of Bioequivalence & Bioavailability

Takeharu Ogura

Publications

• Research Article
  Bioequivalence Studies of A Generic Formulation (SW651K) to the Brand Drug S-1 in Tumor-Bearing Rat Models
  Author(s): Tomoyuki Okabe, Takeharu Ogura, Takashi Yoshimura, Yoshiyuki Tanaka, Hiromu Toyoda, Ken-ichi Fujita and Yasutsuna SasakiTomoyuki Okabe, Takeharu Ogura, Takashi Yoshimura, Yoshiyuki Tanaka, Hiromu Toyoda, Ken-ichi Fujita and Yasutsuna Sasaki
  
  SW651K, a fixed combination of tegafur (FT), 5-chloro-2,4-dihydroxypyridine (CDHP) and potassium oxonate (Oxo), is a generic preparation of S-1, which is widely used to treat gastric cancer in Japan. There is little detailed information of pharmacological effects of SW651K in clinical therapy. However it is not easy to evaluate the PK/PD in clinical trial. Therefore this study examined the bioequivalence of SW651K to S-1 in terms of pharmacokinetics and tumor shrinkage in tumor-bearing rats. Bioequivalence of SW651K to S-1 was first evaluated in Yoshida sarcomabearing rats. Concentrations of FT, 5-fluorouracil (5-FU, the active metabolite of FT), CDHP, and Oxo in plasma, tumor, small intestine, and large intestine were analyzed after a single dose of SW651K. Tumor size was measured during treatment with each formulation for 7 consecutive days. Next, tumor .. View More»
  DOI: 10.4172/jbb.1000279

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