NCT01285505WithdrawnPhase 1
Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To An Alprazolam Sublingual Tablet
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.0 sitesStarted: April 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Alprazolam bioavailability as assessed from the area under the concentration-time curve (AUC)
Study Overview
Brief Summary
This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing sublingual formulation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy male or female subjects
- •BMI 18 to 26.9
- •must give informed consent
Exclusion Criteria
- •clinically significant disease
- •narrow angle glaucoma
- •positive drug screen
Arms & Interventions
Alprazolam commercial sublingual tablet
Active Comparator
Intervention: alprazolam commercial sublingual formulation (Drug)
Alprazolam test sublingual tablet
Experimental
Intervention: alprazolam test sublingual tablet (Drug)
Outcomes
Primary Outcomes
Alprazolam bioavailability as assessed from the area under the concentration-time curve (AUC)
Time Frame: 11 days
Alprazolam bioavailability as assessed by peak concentration (Cmax)
Time Frame: 11 days
Secondary Outcomes
- Alprazolam time of maximum concentration (Tmax)(11 days)
- Half life of alprazolam(11 days)
- Clinically significant safety laboratory tests(11 days)
- Clinically significant adverse events(11 days)
- Clinically significant vital signs(11 days)
Investigators
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