This study aims to compare the pharmacokinetics of naloxone when administered as the Mitovie nasal spray (Test Product) and as a solution for injection (Comparator Product) administered intranasally using a mucosal atomization device (MAD).
Naloxone hydrochloride is currently only recommended and licensed for intravenous, intramuscular and subcutaneous administration. It has also been used by intranasal administration (off-label use) when the intravenous route is not suitable by administering the Solution for Injection using a mucosal atomization device (MAD). However, due to the volume of naloxone solution administered this way, some of it may be inadvertently swallowed and not absorbed into the nasal mucosa and the product requires administration by medically trained personnel. The study aims to investigate intranasal administration of naloxone using a more concentrated solution and a nasal delivery device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
International Pharmaceutical Research Center (IPRC)
Amman, Jordan
Pharmacokinetics
Plasma concentration time profiles and area under the curve (AUC), maximum concentation (Cmax), Time to maximum concentration (Tmax), elimination rate constant (Kel) and terminal half life (t1/2)
Time frame: 0, 5, 10, 15, 20, 30 and 45 minutes and 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00 and 12.00 hours for each arm
Number of subjects with adverse events
Continuous adverse event monitoring during the study with prompted assessments in the 12 hours post-dose
Time frame: 14 days
Physical Examination
Complete physical examination at screening and final follow-up and specific nasal examination post-dose
Time frame: 14 days
Vital signs
Vital signs at screening, final follow-up and pre- and post-dose
Time frame: 14 days
ECGs
ECGs at screening and final follow-up
Time frame: 14 days
Safety Laboratory Tests
Haematology, biochemistry and urinalysis at screening and final follow-up
Time frame: 14 days
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