67630-00-6 Tert-butoxycarbonyl-4-NO2-phenylalanine-ethyl ester

ʻO Nidanib, he mea kemika.Inoa kemika 1 h - indole - 6 - carboxylic acid, 2, 3 - dihydro - 3 - [[[4 - (methyl [(4 - methyl - 1 - piperazine) acetyl] amino] phenyl] amino] benzene heartland of methyl] - 2 - oxygen -, methyl ester, (z) - Hoʻohana ʻia kēia huahana no ka mālama ʻana i ka idiopathic pulmonary fibrosis (IPF).
Ua aʻo ʻo Nidanib i nā mea maʻi 1,529 me ka idiopathic pulmonary fibrosis (IPF) i nā hoʻokolohua lapaʻau he nui.Hoʻokumu ʻia ka ʻikepili palekana i hōʻike ʻia ma ka hoʻohālikelike ʻana o nā maʻi 1061 i hāʻawi ʻia i ka nidanib 150 mg ʻelua i kēlā me kēia lā a me kahi placebo i ʻelua 52-week phase 3, randomized, double-blind, placebo-controlled studies (INPULSIS-1 a me INPULSIS-2).ʻO nā mea ʻino loa e pili ana i ka hoʻohana ʻana i ka nidanib, ʻo ia ka maʻi maʻi, nausea a me ka luaʻi ʻana, ka ʻeha o ka ʻōpū, ka pau ʻana o ka ʻai, ka pohō kaumaha, a me nā enzymes ate kiʻekiʻe.E ʻoluʻolu e nānā i [Precautions] no ka mālama ʻana i nā hopena ʻino e pili ana.Hāʻawi ka Systematic Organ Classification (SOC) o MedDRA i kahi hōʻuluʻulu o nā hopena ʻino a me ka helu pinepine.
ʻO Nidanib kahi substrate no P-gp (e nānā i ka Pharmacokinetics).Ma kahi noiʻi kikoʻī o ka pili ʻana i nā lāʻau lapaʻau, hui pū ʻia ka ketoconazole, kahi mea hoʻopaneʻe P-gp ikaika, hoʻonui i ka ʻike ʻana i ka nidanib i 1.61 mau manawa ma ka wahi ma lalo o ka pihi (AUC) a me 1.83 mau manawa e ka peak concentration (Cmax).
Ma kahi noiʻi hoʻopili lāʻau me ka ikaika P-gp inducer rifampicin, ua emi ka ʻike ʻana i ka nidanib i 50.3%, e like me ke ana ʻana ma lalo o ka pihi (AUC), ke hui pū ʻia me ka rifampicin i hoʻohālikelike ʻia me Nidanib wale nō.Ma muli o ka manaʻo kiʻekiʻe (Cmax), ua emi i ka 60.3%.
Ke hoʻohana pū ʻia me kēia huahana, hiki i nā mea paʻa P-gp ikaika (e laʻa, ketoconazole a i ʻole erythromycin) ke hoʻonui i ka ʻike i ka nidanib.I kēia mau hihia, pono e nānā pono ʻia ka hoʻomanawanui o ka mea maʻi i ka nidanib.ʻO ka mālama ʻana i nā hopena ʻino e koi ai i ka hoʻopau ʻana, ka hoʻemi ʻana i ka dosing, a i ʻole ka hoʻopau ʻana i ka mālama ʻana me kēia huahana (e ʻike i ka [Hoʻohana a me ka dosage]).
Hiki i nā mea hoʻoulu ikaika P-gp (e laʻa, rifampicin, carbamazepine, phenytoin a me St. John's wort) hiki ke hōʻemi i ka ʻike ʻana i ka nidanib.Pono e noʻonoʻo ʻia nā hui like ʻole me ka ʻole a i ʻole ka liʻiliʻi o ka induction P-gp.