The 'go to' European specialist pharma company
Norgine is committed to making information about its clinical research publicly available, irrespective of the outcomes, positive or negative, in order to support the scientific understanding of its medicines and medical devices and their benefits and risks to patients.
Norgine discloses clinical trial results of all new medicines and medical devices in accordance with the regulations to ensure rigorous assessment of their quality, safety and efficacy before they are approved and made available to patients. Regulatory review is maintained throughout the life cycle of our medicines and medical devices and the benefits and risks associated with these medicines and medical devices are continuously reviewed by Norgine in collaboration with regulatory authorities.
The results of our clinical trials in all stages of clinical development are disclosed in several ways:
· ClinicalTrials.gov (www.clinicaltrials.gov) and/or
· EudraCT (http://www.eudrapharm.eu/eudrapharm) and/or
· In the scientific literature and/or
· Norgine.com (see below)
NRL994-01/2007 (GLO) (PPL-1093)
An open-label, randomised 2 part scintigraphic study in 2 parallel groups of healthy male subjects. Each group attended the clinical unit for a baseline period (administered water) and a test period (administered KLEAN-PREP® or MOVIPREP®).
A double-blind, randomised, single dose, crossover study to investigate the plasma clearance of two different doses of CLF (NRL972) in 24 volunteers with stable non-cholestatic liver cirrhosis
A randomised, placebo-controlled, double-blind, double-dummy, four-way crossover, single-centre study to investigate the effects of 2 mg and 10 mg intravenously administered NRL972 on the QTC interval in healthy volunteers
A single-centre, open, controlled, randomised cross-over study in healthy male and female volunteers to investigate the effects of the injection volume and injection time on the pharmacokinetics of cholyl-lysyl-fluorescein (NRL972).
A single-centre, open, uncontrolled study in healthy male and female volunteers to describe the plasma pharmacokinetics of cholyl-lysyl-fluorescein (NRL972) during and after a constant rate i.v. infusion
A multi-centre, open, short term follow-up Phase II study to evaluate the clearance of NRL972 in patients undergoing alcohol withdrawal commencing in a controlled clinical setting
NRL972 (CIR) PK Study Summary
A multi-centre, multi-national open study in patients with hepatic cirrhosis to characterise the association between the pharmacokinetics of NRL972 and disease severity
A single-centre, open, controlled, randomised cross-over study in healthy male and female volunteers to evaluate the pharmacokinetics of cholyl-lysyl-fluorescein (NRL972) in the presence of medication-induced changes in cytochrome P450 or biliary transporter proteins.
An open, randomised study to compare the reproducibility of CTP rating and NRL972 pharmacokinetics in patient volunteers with hepatic cirrhosis.
A randomised, open, controlled crossover study in male and female healthy volunteers to describe the plasma pharmacokinetics of cholyl-lysyl-fluorescein (NRL972) during and after a constant rate 2 hour iv-infusion of 5 and 15 mg NRL972 per hour.
Pilot study to assess the diagnostic value of the cholyl lysyl fluorescein (NRL972) assay in cystic fibrosis patients with known advanced liver disease.