Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet
Phase 1
Completed
- Conditions
- Anxiety Disorder
- Interventions
- Registration Number
- NCT01256151
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
To assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Alprazolam sublingual tablet Alprazolam sublingual Alprazolam sublingual tablet Alprazolam conventional tablet Alprazolam tablet Alprazolam conventional tablet
- Primary Outcome Measures
Name Time Method Peak concentration of alprazolam 72 hours Area under the curve (AUC) from time zero to last measurable time of alprazolam 72 hours
- Secondary Outcome Measures
Name Time Method AUC% extrapolated 72 hours Time of Cmax 72 hours Area under the curve from time zero to infinity 72 hours half-life of alprazolam 72 hours Clinically significant safety laboratory tests Screening, Day 0, Day 4 Clincally significant vital signs Screening, Day 4 Clinically significant adverse events 1 month
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New Haven, Connecticut, United States