通用名称

doxycycline monohydrate; doxycycline hyclate; doxycycline calcium; doxycycline hyclate

儿科标签批准日期

2019/12/20 0:00:00

特定指示/秒

Postmarketing study

标签更改摘要

- Population pharmacokinetic analysis of sparse concentration-time data of doxycycline following standard of care intravenous and oral dosing in 44 children (2-18 years) showed that allometrically-scaled clearance of doxycycline in children ≥2 to ≤8 years did not differ significantly from children >8 to 18 years. - No clinically significant difference in CL differences between oral and IV were observed in the small cohort of pediatric patients who received the oral (N=19) or IV (N=21) formulation alone. - Off-patent written request.

治疗类别

Anti-Infective

立法类型

409I(BPCA)

产品说明书链接

书号

1.0

研究年龄

19 DAYS - 20 YEARS

学习类型

Safety,Pharmacokinetic

研究设计

Multicenter,Population PK,Phase 1,Prospective

登记的患者

52

患者分析

47

中心的数量

15

国家数量

1

西班牙裔拉美裔/拉丁裔总计

2

非西班牙裔/非拉丁裔总人数

45

总数#种族不明

0

亚裔学生总数

0

黑人总数

9

白人总数

37

夏威夷或太平洋岛民总数

0

美洲印第安人/阿拉斯加本地人总数

0

其他种族总计

0

未知种族总数

1

国家

United States