Anxiety Disorder
Conditions
Keywords
Bioequivalence, sublingual, alprazolam, pharmacokinetics
Brief summary
To assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam.
Interventions
1 mg single dose of alprazolam conventional tablet
DRUGAlprazolam sublingual
1 mg single dose of alprazolam sublingual tablet
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2. * Signed informed consent.
Exclusion criteria
* Evidence or history of clinically significant abnormalities * Positive drug screen, excessive alcohol and tobacco use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC) from time zero to last measurable time of alprazolam | 72 hours |
| Peak concentration of alprazolam | 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| Time of Cmax | 72 hours |
| half-life of alprazolam | 72 hours |
| Area under the curve from time zero to infinity | 72 hours |
| Clincally significant vital signs | Screening, Day 4 |
| Clinically significant adverse events | 1 month |
| Clinically significant safety laboratory tests | Screening, Day 0, Day 4 |
| AUC% extrapolated | 72 hours |
Countries
United States
Outcome results
None listed