An Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of Cysteamine Bitartrate Delayed-release Capsules (RP103) for Treatment of Children with Inherited Mitochondrial Disease (RP103-MITO-001)

Cohen Bruce H.; Enns Gregory M.; Haas Richard; Longo Nicola; Scaglia Fernando; Lang William; Sile Saba

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An Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of Cysteamine Bitartrate Delayed-release Capsules (RP103) for Treatment of Children with Inherited Mitochondrial Disease (RP103-MITO-001)

机译：评估剂量的酒石酸氨基硬脂酸半胱氨酸缓释胶囊（RP103）的安全性，耐受性，疗效，药代动力学和药效动力学的开放标签，剂量递增研究（RP103-MITO-001）

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《Mitochondrion》 |2016年第null期|共1页
作者
Cohen Bruce H.; Enns Gregory M.; Haas Richard; Longo Nicola; Scaglia Fernando; Lang William; Sile Saba;
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1. An Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of Cysteamine Bitartrate Delayed-release Capsules (RP103) for Treatment of Children with Inherited Mitochondrial Disease (RP103-MITO-001) [J] . Cohen Bruce H., Enns Gregory M., Haas Richard, Mitochondrion . 2016,第Null期

机译：评估剂量的酒石酸氨基硬脂酸半胱氨酸缓释胶囊（RP103）的安全性，耐受性，疗效，药代动力学和药效动力学的开放标签，剂量递增研究（RP103-MITO-001）
2. Safety and tolerability of a new formulation of pancrelipase delayed-release capsules (CREON) in children under seven years of age with exocrine pancreatic insufficiency due to cystic fibrosis: an open-label, multicentre, single-treatment-arm study. [J] . Graff GR, McNamara J, Royall J, Clinical drug investigation . 2010,第6期

机译：一种新配方的胰酶延迟释放胶囊（CREON）在因囊性纤维化而导致外分泌性胰腺功能不全的7岁以下儿童中的安全性和耐受性：一项开放性，多中心，单次治疗的研究。
3. A Phase 1 Pharmacokinetic Study of Cysteamine Bitartrate Delayed-Release Capsules Following Oral Administration with Orange Juice, Water, or Omeprazole in Cystinosis [J] . Danielle Armas, Robert J. Holt, Nils F. Confer, Advances in therapy. . 2018,第2期

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4. A Phase 1 Pharmacokinetic Study of Cysteamine Bitartrate Delayed-Release Capsules Following Oral Administration with Orange Juice Water or Omeprazole in Cystinosis [O] . Danielle Armas, Robert J. Holt, Nils F. Confer, -1

机译：口服橙汁水或奥美拉唑口服治疗酒后尿毒症中酒石酸半胱胺酸缓释胶囊的1期药代动力学研究
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机译：新型酶替代治疗的安全性，可耐药性，药代动力学，药效学和探索性疗效脂肪溶酶酶Alfa（Neogaa）治疗 - 幼稚和alglucosidase Alfa治疗的晚期疾病患者：1期，开放标签，多中心，跨国，上升剂量学习

An Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of Cysteamine Bitartrate Delayed-release Capsules (RP103) for Treatment of Children with Inherited Mitochondrial Disease (RP103-MITO-001)

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