TOBI 300 mg/5 ml, solution pour inhalation par nébuliseur ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
299嚢胞性線維症1

299. 嚢胞性線維症


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-019634-26-FR
(EUCTR)
08/02/2011A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy ofMP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis PatientsA Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy ofMP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis Patients Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
MedDRA version: 9.1;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: Aeroquin
Product Code: MP-376
INN or Proposed INN: levofloxacin
Other descriptive name: levofloxacin hemihydrate
Trade Name: TOBI 300 mg/5 ml, solution pour inhalation par nébuliseur
INN or Proposed INN: TOBRAMYCIN
Mpex Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
330Phase 3France;Ireland;Germany;United Kingdom