[Translation] Study on the relative bioavailability of mercaptopurine microtablets under postprandial conditions
本试验旨在研究单次餐后口服华润双鹤药业股份有限公司研制、生产的巯嘌呤微片(5 mg)的药代动力学特征;以Quinn Pharmaceuticals持证的巯嘌呤片(50 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体药代动力学差异。
探索性分析:评价两制剂的人体生物等效性。
[Translation] This trial aims to study the pharmacokinetic characteristics of mercaptopurine microtablets (5 mg) developed and produced by China Resources Shuanghe Pharmaceuticals Co., Ltd. after a single oral administration; using Quinn Pharmaceuticals' licensed mercaptopurine tablets (50 mg) As a reference preparation, compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations to evaluate the differences in human pharmacokinetics between the two preparations.
Exploratory analysis: To evaluate the human bioequivalence of the two formulations.
The Efficacy of Oral Prednisone in Treating Langerhans Cell Histiocytosis of Bone in Childhood and Adolescence: A Multi-center, Open-label, Randomized-controlled, Phase II Study
Langerhans cell histiocytosis (LCH) of bone is a benign-tumor-like osteolytic lesion in childhood and adolescence, which is characterized by the aberrant activation of antigen presenting cells. Rather than the multi-system involvements of LCH, no standard or widely-accepted therapeutic regimens were established for LCH of bone. In the previous clinical practice, several LCH patients obtained remarkable pain relief after taking prednisone. Therefore, the investigators aim to conducting a multi-center, open-labelled, randomized-controlled, Phase II study to investigate the efficacy and safety of oral prednisone in treating LCH of bone in children and adolescents. The enrolled patients will be randomly recruited to the following groups: (1) Oral prednisone [Test group); (2) Regular observation [Control group].
[Translation] Bioequivalence study of mercaptopurine microtablets in human body
本试验旨在研究单次空腹口服华润双鹤药业股份有限公司研制、生产的巯嘌呤微片(5 mg)的药代动力学特征;以Quinn Pharmaceuticals, LLC持证的巯嘌呤片(50 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] This experiment aims to study the pharmacokinetic characteristics of mercaptopurine microtablets (5 mg) developed and produced by China Resources Double-Crane Pharmaceutical Co., Ltd. after a single oral administration on an empty stomach; mercaptopurine tablets (50 mg ) as the reference preparation, compare the pharmacokinetic parameters Cmax, AUC0-t, AUC0-∞ of the two preparations, and evaluate the human bioequivalence of the two preparations.
100 Clinical Results associated with Beijing Children's Hospital.Captital Medical University
0 Patents (Medical) associated with Beijing Children's Hospital.Captital Medical University
100 Deals associated with Beijing Children's Hospital.Captital Medical University
100 Translational Medicine associated with Beijing Children's Hospital.Captital Medical University