Trial Outcomes & Findings for A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers (NCT NCT01364558)
NCT ID: NCT01364558
Last Updated: 2019-11-01
Results Overview
To calculate bioavailability we used the following formula: Area Under the Curve (Intranasal Spray)\*100/Area Under the Curve (Intravenous Injection)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
2 days
Results posted on
2019-11-01
Participant Flow
All 24 subjects were given each formulation with a two week wash out period.
Participant milestones
| Measure |
Diazepam Nasal Spray Suspension
Diazepam Nasal Spray Suspension
|
Diazepam Nasal Spray Solution
Diazepam Nasal Spray Solution
|
Diazepam Injection
Diazepam injection
|
|---|---|---|---|
|
Dose One
STARTED
|
8
|
8
|
8
|
|
Dose One
COMPLETED
|
8
|
8
|
8
|
|
Dose One
NOT COMPLETED
|
0
|
0
|
0
|
|
Dose Two
STARTED
|
8
|
8
|
8
|
|
Dose Two
COMPLETED
|
8
|
8
|
8
|
|
Dose Two
NOT COMPLETED
|
0
|
0
|
0
|
|
Dose Three
STARTED
|
8
|
8
|
8
|
|
Dose Three
COMPLETED
|
8
|
8
|
8
|
|
Dose Three
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Diazepam Nasal Spray Suspension/Spray/Injection
n=24 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 7.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 daysTo calculate bioavailability we used the following formula: Area Under the Curve (Intranasal Spray)\*100/Area Under the Curve (Intravenous Injection)
Outcome measures
| Measure |
Diazepam Nasal Spray Suspension
n=24 Participants
Diazepam Nasal Spray Suspension
|
Diazepam Nasal Spray Solution
n=24 Participants
Diazepam Nasal Spray Solution
|
Diazepam Injection
n=24 Participants
Diazepam injection
|
|---|---|---|---|
|
Comparison of the Absolute Bioavailability of Two Intranasal Diazepam Formulations.
|
69 Percentage of Bioavailability
Interval 64.0 to 75.0
|
96.82 Percentage of Bioavailability
Interval 90.0 to 105.0
|
100 Percentage of Bioavailability
Interval 100.0 to 100.0
|
Adverse Events
Diazepam Nasal Spray Suspension
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Diazepam Nasal Spray Solution
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Diazepam Injection
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diazepam Nasal Spray Suspension
n=24 participants at risk
|
Diazepam Nasal Spray Solution
n=24 participants at risk
|
Diazepam Injection
n=24 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
|
General disorders
General Disorders
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Infections and infestations
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
|
Nervous system disorders
Nervous system disorders
|
16.7%
4/24 • Number of events 4
|
12.5%
3/24 • Number of events 3
|
25.0%
6/24 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Respitory, thoracic, and mediastinal disorders
|
20.8%
5/24 • Number of events 5
|
25.0%
6/24 • Number of events 6
|
25.0%
6/24 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
|
Vascular disorders
Vascular disorders
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
Additional Information
Dr. James Cloyd, Director for Center for Orphan drug research
University of Minnesota
Phone: 612-624-4609
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place