8
Participants
Start Date
March 5, 2024
Primary Completion Date
May 13, 2024
Study Completion Date
September 2, 2024
Intravenous naloxone
Nyoxid 1.8 mg nasal spray, solution in single-dose container. Study drugs (naloxone nasal spray and naloxone intravenously) will be administered in 8 subjects in two sequences in fasting conditions (10 hours pre-dose and 4 hours post dose): Intranasal -\> washout period -\>intravenous (n=4) and Intravenous -\>washout period -\> intranasal (n=4).
Intranasal naloxone
Naloxone Kern Pharma 1 mg in total (from 0.4 mg/mL injectable solution). Study drugs (naloxone nasal spray and naloxone intravenously) will be administered in 8 subjects in two sequences in fasting conditions (10 hours pre-dose and 4 hours post dose): Intranasal -\> washout period -\>intravenous (n=4) and Intravenous -\>washout period -\> intranasal (n=4).
Hospital del Mar Research Institute, Barcelona
IMIM (Hospital del Mar Medical Research Institute), Barcelona
Food and Drug Administration (FDA)
FED
Parc de Salut Mar
OTHER