299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2007-000959-33-DE (EUCTR) | 16/08/2007 | 04/04/2007 | Randomized, open labelled, cross over deposition study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS® in subjects with CF | Randomized, open labelled, cross over deposition study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS® in subjects with CF | Cystic Fibrosis with Pseudomonas aeruginosa infection | Product Name: Tobramycin 100 PARI Product Code: T100 PARI INN or Proposed INN: Tobramycin Trade Name: TOBI® INN or Proposed INN: Tobramycin | PARI GmbH | NULL | Not Recruiting | Female: yes Male: yes | 25 | Germany | |||
| 2 | EUCTR2005-004103-10-DE (EUCTR) | 03/05/2006 | 30/01/2006 | Randomized, open labeled, multi center, active controlled, parallel 28 days safety and bioavailability study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS in cystic fibrosis patients with Pseudomonas Aeruginosa infections | Randomized, open labeled, multi center, active controlled, parallel 28 days safety and bioavailability study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS in cystic fibrosis patients with Pseudomonas Aeruginosa infections | Cystic Fibrosis with Pseudomoas aeuriginosa infection MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Tobramycin 100 PARI Product Code: T100 PARI INN or Proposed INN: Tobramycin Trade Name: Tobi Product Name: TOBI® INN or Proposed INN: Tobramycin | PARI Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Germany | |||
| 3 | EUCTR2010-023235-41-PL (EUCTR) | 28/01/2011 | A comparative, randomised, two period, multi-center, cross-over 14 weeksbioequivalence study of Tobramycin PARI (T100) versus TOBI® (Novartis) incystic fibrosis patients with bronchopulmonary chronic Pseudomonasaeruginosa infection - T-100 BE | A comparative, randomised, two period, multi-center, cross-over 14 weeksbioequivalence study of Tobramycin PARI (T100) versus TOBI® (Novartis) incystic fibrosis patients with bronchopulmonary chronic Pseudomonasaeruginosa infection - T-100 BE | Cystic fibrosis with bronchopulmonary chronic Pseudomonas aeruginosa infection MedDRA version: 12.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Tobramycin Product Code: T100 INN or Proposed INN: Tobramycin Other descriptive name: Tobramycinum Trade Name: TOBI® INN or Proposed INN: TOBRAMYCIN | PARI Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 1 | Poland |