Pharmacokinetic similarity study of levodopa/carbidopa [ND0612H] to Duodopa in healthy volunteers
Phase of Trial: Phase I
Latest Information Update: 01 Mar 2017
At a glance
- Drugs Levodopa/carbidopa (Primary)
- Indications Parkinson's disease
- Focus Pharmacokinetics
- Acronyms Trial 009
- 01 Mar 2017 According to NeuroDerm media release, based on minutes from a meeting held in January 2017 with the EMA and the preliminary results of trial 006 (CT profile 261957), company has modified its EU clinical and regulatory development path. The modified strategy will be based on restarted and amended iNDiGO trial (CT profile 252739), rather than on bioequivalent pharmacokinetic (PK) studies. Hence this study will not be carried out.
- 01 Mar 2017 Status changed from planning to discontinued, according to a NeuroDerm media release.
- 25 Aug 2016 According to a NeuroDerm media release, this trial is expected to initiate at the end of 2016 or beginning of 2017.