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In open-label, randomized, three-period, three-treatment crossover studies, 10 subjects received 10 mg A, 45 mg B or the combination, while20 subjects received 20 mg A, 1000 mg C or the combination. In an open-label, randomized, five-period, five-treatment, unbalanced crossover study, 12 subjects first received 20 mg A, 4 mg D or the combination, and afterward 100 mg sitagliptin or sitagliptin plus 20 mg A. Blood samples were taken over 72 h of each treatmentperiod. Lack of PK interaction was defined as the ratio of geometric means and 90% confidence interval (CI) for combination:monotherapy being within the range of 0.80¨C1.25 ¡£ Co-administration of A withB, C or D had no effect on A maximum plasma concentration (Cmax) or area under the plasma concentration-time curve (AUC). Similarly, A did not affect the Cmax or AUC for the co-administered drug, except for slight extensions of the 90% CI for the ratio of geometric means for B AUC (upper limit 1.29) andC Cmax (lower limit 0.75). All monotherapies and combination therapies were well tolerated. A can be co-administered with B¡¢C¡¢Dwithout dose adjustment of either drug |
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Mally89
Ìú¸Ëľ³æ (Ö°Òµ×÷¼Ò)
T_T
- ·ÒëEPI: 79
- Ó¦Öú: 7 (Ó×¶ùÔ°)
- ¹ó±ö: 1.257
- ½ð±Ò: 5347.3
- É¢½ð: 8936
- ºì»¨: 49
- Ìû×Ó: 3712
- ÔÚÏß: 1225.5Сʱ
- ³æºÅ: 1150928
- ×¢²á: 2010-11-19
- ÐÔ±ð: MM
- רҵ: Ö×ÁöÃâÒß
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sltmac(½ð±Ò+41, ·ÒëEPI+1): 2011-05-16 07:52:15
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sltmac(½ð±Ò+41, ·ÒëEPI+1): 2011-05-16 07:52:15
sltmac: ¼ÌÐøÅ¬Á¦~~ 2011-05-16 07:52:30
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In open-label, randomized, three-period, three-treatment crossover studies, 10 subjects received 10 mg A, 45 mg B or the combination, while20 subjects received 20 mg A, 1000 mg C or the combination. In an open-label, randomized, five-period, five-treatment, unbalanced crossover study, 12 subjects first received 20 mg A, 4 mg D or the combination, and afterward 100 mg sitagliptin or sitagliptin plus 20 mg A¡£ ÔÚ½øÐгÖÐøÈý¸öÖÜÆÚ£¬Ëæ»ú¿ª·Å±ê¼ÇµÄÈý¸ö´¦Àí½»²æÖÎÁÆÑо¿µ±ÖУ¬10¸öÑù±¾ÖмÓÈë10mgµÄA£¬45mgµÄB»òÕß¶þÕߵĻìºÏÎÁíÍâ20¸öÑù±¾ÖмÓÈë20mgµÄA¡¢1000mgµÄC»òÕß¶þÕߵĻìºÏÎï¡£ÔÚÁíÒ»¸öËæ»ú¿ª·Å±ê¼Ç£¬Î¬³Ö5¸öÖÜÆÚµÄ5¸ö½»²æ²»Æ½ºâ´¦ÀíÑо¿µ±ÖУ¬Ê×ÏÈÏò12¸öÑù±¾ÖмÓÈë20mg A£¬4mg D»òÕß¶þÕß»ìºÏÎȻºóÔÙ¼ÓÈë100mgÎ÷ËûÁÐÍ¡»ò¼ÓÓÐ20mgAµÄÎ÷ËûÁÐÍ¡¡£ |
5Â¥2011-05-08 15:22:48
Mally89
Ìú¸Ëľ³æ (Ö°Òµ×÷¼Ò)
T_T
- ·ÒëEPI: 79
- Ó¦Öú: 7 (Ó×¶ùÔ°)
- ¹ó±ö: 1.257
- ½ð±Ò: 5347.3
- É¢½ð: 8936
- ºì»¨: 49
- Ìû×Ó: 3712
- ÔÚÏß: 1225.5Сʱ
- ³æºÅ: 1150928
- ×¢²á: 2010-11-19
- ÐÔ±ð: MM
- רҵ: Ö×ÁöÃâÒß
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Blood samples were taken over 72 h of each treatment period. Lack of PK interaction was defined as the ratio of geometric means and 90% confidence interval (CI) for combination:monotherapy being within the range of 0.80¨C1.25 ¡£ ÿ¸ö´¦ÀíÖÜÆÚ72Сʱ֮ºó½«ÑªÒºÑù±¾È¡³ö¡£¸ù¾Ý¼¸ºÎ·½·¨ºÍ»ìºÏÎï90%ÖÃÐÅÇø¼ä£¨ÔÚ0.8-1.25·¶Î§Äڵĵ¥Ò»ÖÎÁÆ£©µÄ±ÈÖµÀ´Åж¨½»²æ·´Ó¦ÖÐÊÇ·ñȱ·¦PK¡£ |
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