A Pharmacokinetic Study to Assess Dose Proportionality, Safety and Tolerability of Diazepam Nasal Spray in Healthy Adult Volunteers
Status: | Recruiting |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/21/2016 |
Start Date: | January 2016 |
End Date: | May 2016 |
A Two-Period, Randomized, Open-Label, Crossover Pharmacokinetic Study to Assess Dose Proportionality, Safety and Tolerability of Diazepam Nasal Spray in Healthy Adult Volunteers
This is a single-center, two-period, randomized, open-label, crossover pharmacokinetic (PK)
study in healthy adult volunteers to evaluate dose proportionality of diazepam nasal spray
using two dose levels
study in healthy adult volunteers to evaluate dose proportionality of diazepam nasal spray
using two dose levels
Inclusion Criteria:
- Screening body weight 88 to 111 kg, inclusive;
- General good health with no clinically significant abnormalities that would affect
ability to complete study as determined by medical history, physical examination,
visual evaluation of the septum and turbinates to document baseline anatomy,
electrocardiogram, clinical laboratory test results;
- Negative drug and alcohol testing;
- Negative pregnancy test for female subjects of childbearing potential.
Exclusion Criteria:
- Subject who is not surgically sterile or female subject who is less than 2 years
postmenopausal, and who does not agree to use a highly effective birth control method
during the study and up to 3 months after the last dose of investigational product;
- In the judgment of the Investigator, any clinically significant abnormality (such as
septal perforations) or illness that would interfere with participation in this study
as determined by medical history, physical examination (including visual exam of
septum and turbinates), ECG, clinical laboratory results, or other screening safety
tests;
- Any other condition and/or situation that causes the investigator to deem a subject
unsuitable for the study.
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