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1

2 1.4 特 許 状 況

3 - 1 -

4 - 2 -

5 1.5 起 原 又 は 発 見 の 経 緯 及 び 開 発 の 経 緯

6 FCT CT RH

7 i

8 10mg FCT mg CT mg CT mg mg mg FCT 5mg CT 109 4mg CT 82 4mg mg mg FCT % 525% 1020% 10 15% mg 5mg mg 10mg - 1 -

9 10mg FCT 5mg FCT 10mg FCT 5mg FCT 5mg FCT 25/60%RH 36 40/75%RH 6 FCT 6 15 CT 10mg FCT25 10mg CT t 1/2 10mg FCT4.6hr 210mg CT3.84.8hrTmax 10mg FCT CT 10mg FCT4.0hr210mg CT 2.0hr AUC 0- Cmax 10mg AUC 0- CT 10mg FCT Cmax CT 10mg FCT mg FCT CT Cmax 90%25 10mg 0.80, 1.25FCT CT in vivo in vivo D mg 20mg1 1 10mg 20mg - 2 -

10 10mg mg 10mg mg mg mg mg

11 5mg 10mg 5mg 10mg 5mg 10mg 10mg 5mg 10mg 5mg 10mg 5mg 5mg 10mg 20 5mg 10mg 5mg 10mg 5mg 10mg 10mg 5mg 5mg 10mg 5mg 10mg 5mg 10mg 12 5mg 10mg

12 10mg 1 1 5mg 10mg

13 5mgFCT 5mgFCT - 6 -

14 - 7 -

15 1.6 外 国 における 使 用 状 況 等 に 関 する 資 料

16 WPC USPC EUSPC FCT CT ALT AST AUC CYP P450

17 i

18 WPCUSPCEUSPC WPCUSPC EUSPC 10mg FCT mg CT mg CT 4mg mg FCT mg FCT 10mg FCT 5mg CT4mg CT 4mg 10mg FCT5mg CT4mg CT 4mg SINGULAIR SINGULAIR - 1 -

19 SINGULAIR FCT/10mg CT/5mg CT/4mg 2002/05/14 /4mg 2005/02/22 SINGULAIR 2002/10/ /03/24 FCT/10mg CT/5mg CT/4mg mg FCT mg CT mg CT 1 4mg mg mg FCT mg CT mg CT

20 SINGULAIR FCT/10mg CT/5mg 15 CT/4mg 2 10mgFCT /12/31 /4mg /7/27 6 5mg CT mg CT1 4mg mg SINGULAIR SINGULAIR Baby 2003/02/20 FCT/10mg CT/5mg CT/4 mg /4mg SINGULAIR SINGULAIR Baby mg FCT mg CT mg CT 1 4mg

21 Rino SINGULAIR TM 2004/01/21 FCT/10mg 15 10mg FCT Rino SINGULAIR TM SINGULAIR 1 1 SINGULAIR 2004/11/03 FCT/10mg SINGULAIR SINGULAIR 2004/03/25 FCT/10mg Allergy TM SINGULAIR 2004/11/03 FCT/10mg SINGULAIR 15 10mg FCT mg FCT SINGULAIR Allergy TM SINGULAIR mg FCT

22 - 5 -

23 - 6 -

24 - 7 -

25 SINGULAIR 10mg FCT1 10mg 5mg CT1 5mg 4mg CT1 4mg 4mg 1 4mg mgFCT mg CT mg CT1 4mg mg mL 1 15 β - 8 -

26 Churg-Strauss β 24 β β 4mg 5mg CT 4mg 5mg 0.674mg 0.842mg 35µg/ 1mg 10mg AUC 40% P450 Sprague-Dawley 200mg/kg/day 2 100mg/kg/day 92 1 AUC 120 AUC 75 1 AUC 45 AUC 25 V-79 in vivo - 9 -

27 200mg/kg1 AUC mg/kg1 AUC mg/kg1 AUC 160 B 400mg/kg/day1 AUC mg/kg/day1 AUC mg CT mg AUC mg 5mg CT mg

28 % % ,600 1% % 10mg n1,955% n1,180% ALT AST 2.1 *1 1.6 *1 1.0 *3 *1 n1,935 *2 n1,170 *3 n1,924 *4 n1, *2 1.2 *2 0.9 * %

29 % mg % % 15 2, % 1.9% 1.5% % ,357 1, % ALT

30 Churg-Strauss

31 TRADENAME TM 10mg film-coated tablet FCT1 10mg mg 15 10mg TRADENAME SINGULAIR mg CT Churg-Strauss Churg-Strauss Child-Pugh score >9 Lapp 35µg/ 1mg AUC 40% CYP3A4 CYP3A4 In vitro CYP2C8 CYP2C8 in vivo

32 15 2, /100<<1/ ,000 10mg FCT mg FCT ,750 5mg CT 1/100<<1/ n n n ALTAST Churg-Strauss

33 SINGULAIR 10mg film-coated tablet FCT1 10mg mg β 15 10mg mg CT β β Churg-Strauss Churg-Strauss Lapp

34 35µg/ 1mg AUC 40% CYP3A4 CYP3A4 In vitro CYP2C8 CYP2C8 in vivo 15 4,000 10mg FCT mg FCT ,750 5mg CT 1/100< <1/ n n n ALTAST

35 Churg-Strauss

36 1.7 同 種 同 効 品 一 覧 表

37 CYP ALTGPT γ-gtp Al-P ASTGOT PTP CKCPK LDH P450 γ- Press Through Package

38 i

39 2-1 -

40 5mg 10 5mg ) H Cl N S CO 2 Na OH CH3 CH 3 5mg 5mg 5mg mg 10mg11 510mg 1 1 5mg 5mg Churg-Strauss (7) P450CYP3A4 2C9 CYP3A % % 7 1.3% 6 1.1% 5 1.0% 5 1.0% ALTGPT γ-gtp Al-P , % % % 9 0.5% 5 0.3% 5 0.3% 5 0.3%1% 1, ALTGPT1, , ,

41 % ASTGOTALT GPTAl-P γ-gtp mg mg PTP PTP PTP 2 1) 2) - 3 -

42 H Cl N S CO 2 Na OH CH3 CH 3 5mg 6 5mg Churg-Strauss % % % 2 1.2% 2 1.2%1 0.6% % % 7 1.3% 6 1.1% 5 1.0% 5 1.0%49 9.4%80 ALTGPT 14 -GTP 9 Al-P 8-4 -

43 % AST GOT ALT GPT Al-P γ-gtp PTP PTP PTP

44 4 mg 4 mg CO 2 Na H Cl N S OH CH3 CH mg mg Churg-Strauss 7 8 P450CYP3A4 2C9 CYP3A % Al-P 2-6 -

45 % % 1 0.6% 1 0.6% 1 0.6% 1 0.6% 1 0.6% % % 3 0.8% 2 0.5% 2 0.5%7 2.0% 11 3 ASTGOT mg % % mg % % 2 1.2% 2 1.2% mg % % 7 1.3% 6 1.1% 5 1.0% 5 1.0% %80 ALTGPT 14 γ-gtp 9 Al-P % AST GOT ALT GPT Al-P γ-gtp - 7 -

46 mg mg ml mg mg

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