エクラー軟膏0.3%、エクラークリーム0.3%、エクラーローション0.3%_IF

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1 IF g 3mg(0.3%) Deprodone Propionate ( ) ( ) F A X IF

2 IF 1. MR 63 2 IF 10 3 IF 2. IF IF IF 3. IF A4 9 IF IF IF 11 1 IF IF 4. IF IF MR IF IF MR Drug Safety Update IF

3

4

5 (1) (2) (3) 84.3%(721 /855 ) 96.3%(823 /855 ) 81.4%(664 / %(765 /816 ) 78.5%(520 / %(613 /662 ) (4) 1.0%(9 /859 ) 2.1%(17 /824 ) 1.6%(12 /728 ) - 1 -

6 0.3% 0.3% 0.3% ECLAR OINTMENT 0.3%, ECLAR CREAM 0.3%, ECLAR LOTION 0.3% JAN Deprodone Propionate INN C24H32O (+)-11,17-dihydroxy-1,4-pregnadiene-3,20-dione 17-propionate - 2 -

7 CAS

8 Britton-Robinson (ph210) ( / ) D α g 20mL100mm - 4 -

9 (1) 2mg 2mL 365nm 10mL (2) (1100)1mL 1mL 2 (3) 0.05g 2mL 5 272mL 1 (4) ( ) - 5 -

10 - 6 -

11 1g 3mg0.3 ph (200 ) 3 50m 0.5% ph HP2100-O( ) HP2101C( ) HP2102L( ) 1g 3mg

12 1) - 8 -

13 1) 2) - 9 -

14 1) 0.7g( 2mg ) 10mL 10 30mL 10 1mL 1mL 2 2) 0.7g 10mL 10 30mL 10 1mL 0.02g 10mL 5L (60:15:10:3) 12cm ( 365nm) Rf (0.3) 1) 0.7g( 2mg ) 30mL 30mL 2 1mL 1mL 2 2) 0.7g 30mL 30mL 2 1mL 0.02g 10mL 5L (60:15:10:3) 12cm ( 365nm) Rf (0.3) 1) 0.7g( 2mg ) 20mL 2g 30mL 2 1mL 1mL

15 2) 0.7g 20mL 2g 30mL 2 1mL 0.02g 10mL 5L (60:15:10:3) 12cm ( 365nm) Rf (0.3) 1)3) 0.7g( 2mg ) 20mL 2g 30mL 3 100mL 10mL 10mL g 100mL 2mL 50mL 10mL 10mL 20L QT QS (mg) (mg)qt/qs1/25 n- (120000)

16 ( ) ( ) ( )

17 - 13 -

18 DNA RNA DNA mrna mrna mrna 7)8) 30mg (p<0.01) (p<0.01)

19

20 DP-O Control DP-O 34 5 BV-O DP-O DP-C Control DP-C 34 5 BV-C DP-C ( ) 2 50mg 11) (mg) (%) (mg/100gb.w.) Control DP-O DP-O **,## 31.9 (34.2 a ) **,# BV-O ** **,$$ ( S.E.) DP-O 7 Control DP-O BV-O DP-O BV-O DP-O

21 (mg) (%) (mg/100gb.w.) Control DP-C * DP-C **,## 40.9 (41.7 a ) ** BV-C ** **,$$ ( S.E.) DP-C 7 Control DP-C BV-C DP-C BV-C DP-C BV-O Control 3 (17 )7 (21 ) DP-O BV-O 3 (17 ) 7 (21 ) DP-O BV-O

22 ( ) mg

23 1) 14) 5 2g( 6mg)12 EIA (DP) 12 6,11,17- -1,4- -3, (M2) (4pg/mL)

24 - 20 -

25 20 2g( 6mg) (4pg/mL) 0.06%

26 AUC (pghr/mL) AUC (pghr/mL) AUC (pghr/mL) Kel (hr -1 ) Kel (hr -1 ) Kel (hr -1 ) 7880(%)

27 CYP %

28 2-24 -

29 ODT 3, (0.43%) 4 (0.11%) 4 (0.11%) 4 (0.11%) 4 (0.11%) 2, (1.60%) 13 (0.61%) 7 (0.54%) 6 (0.28%) 5 (0.24%) 5 (0.24%) (1.65) 6 (0.82%) 5 (0.69%) 4 (0.55%) ( ) ODT

30 - 26 -

31 ODT (ODT)

32 - 28 -

33 17) 2) ( ) 80mg/kg 18)19) 1) (SD 5 n=20 20) 0.04mg/kg/day15 2) ( n=3 3) 0.2mg/kg/day13 2mg/kg/day 3) ( n=2 2) 0.1mg/kg/day 1 5mg/kg/day 50mg/kg/day 2 18) 1) (SD 5 n=30 30) mg/kg/day 52 (4 ) 0.04mg/kg/day 0.01mg/kg/day 2) ( n=6 6) mg/kg/day 0.01mg/kg/day 0.01mg/kg/day

34 SD 6 (n=20) 60 (n=20) mg/kg/day 0.08mg/kg/day 0.6mg/kg/day 0.6mg/kg/day 0.08mg/kg/day 0.08mg/kg/day 0.01mg/kg/day (SD 10 n=30) mg/kg/day 0.08mg/kg/day 10mg/kg/day 0.08mg/kg/day ( n=12) mg/kg/day 2mg/kg/day 0.4mg/kg/day 0.08mg/kg/day (SD 10 n=25) mg/kg/day 0.01mg/kg/day 0.08mg/kg/day 0.08mg/kg/day 0.6mg/kg/day 24) (Hartley n=5) ASA PCA 24) (Hartley ) 24) (Hartley ) Maximization

35 25) 3H AUC H AUC H- (0.1mg/kg) H- (0.4mg/kg)

36 (SD ) 3H- (0.6mg/kg) % 8.6% 11.2% 12% (SD ) 3H- (0.6mg/kg) % 10.5% 13.3% 14% 18 3H- 24 ( 0.4mg/kg)

37 g105g5010g10 500g 5g105g5010g10 10g1010g

38 AM 760 4AM AMZ M N Q

39 1) ( ) 2) ( ) 3) ( ) 4) ( ) 5) 0.3%Deprodone Propionate (DP ) 5(9)159,1989 6) DP ( ) 7) 67(10)1935,1985 8) Therapeutic Research5(6)955,1986 9) ( ) 10) DP DP ( ) 11) Deprodone Propionate(DP) ( ) 23(15)93, ) DP-L( ) ( ) 13) Deprodone propionate ( ) 14) ( ) 15) Deprodone propionate(dp) ( ) 16) ( ) 17) DP ( ) 18) ( ) 19) Deprodone Propionate(DP) (6)7, ) Deprodone Propionate(DP) 24(6)25, ) Deprodone Propionate(DP) 24(6)37, ) Deprodone Propionate(DP) 24(6)59, ) ( ) 24) Deprodone Propionate(DP) ( ) 23(15)7,

40 25) ( ) 26) ( ) 27) Deprodone Propionate ( ) 23(15)103, ) ( ) 29) ( ) 30) ( )

41 - 37 -

42 - 38 -

43 MKI10506G ECL DB003A

1 MR 63 2 IF 10 3 IF 2 IF IF IF 3 IF A4 9 IF IF IF 11 1 IF IF 4 IF IF MR IF IF MR Drug Safety Update IF

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