Naloxone Nasal Spray Pharmacokinetic Study
A Phase I Single Dose, Open Label, Randomized, Three Period Crossover Pilot Study to Compare the Pharmacokinetics, Safety and Tolerability of MVP005 Intranasal Spray With Intranasal Administration of Naloxone Solution for Injection in Healthy Adult Subjects
1 other identifier
interventional
6
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2012
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 13, 2012
CompletedFirst Posted
Study publicly available on registry
June 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedJune 20, 2012
June 1, 2012
1 month
June 13, 2012
June 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
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
Secondary Outcomes (5)
Number of subjects with adverse events
14 days
Physical Examination
14 days
Vital signs
14 days
ECGs
14 days
Safety Laboratory Tests
14 days
Study Arms (3)
Test Product Dose 1
EXPERIMENTALTest Product Dose 2
EXPERIMENTALComparator Product
ACTIVE COMPARATORInterventions
2 mg single dose administered intranasally
Eligibility Criteria
You may qualify if:
- Male or female
- years of age
- Provide written informed consent prior to completing any study specific procedure.
- Body Mass Index (BMI) range 18.5-30 kg/m2
- Clinically acceptable medical history, clinical laboratory evaluations, complete physical examination, vital signs and 12 lead ECG
- Using reliable contraception
You may not qualify if:
- Intranasal problems
- Taking prescribed or over the counter medications
- Intake of alcohol, methyl-xanthines or grapefruit or strenuous exercise concurrent with treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
International Pharmaceutical Research Center (IPRC)
Amman, Jordan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abdullah Hiyari, MD
IPRC, Jordan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2012
First Posted
June 19, 2012
Study Start
June 1, 2012
Primary Completion
July 1, 2012
Study Completion
August 1, 2012
Last Updated
June 20, 2012
Record last verified: 2012-06