Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation

Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To An Alprazolam Sublingual Tablet

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01285505

Enrollment

Registered

2011-01-28

Start date

2011-04-30

Completion date

2011-06-30

Last updated

2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

alprazolam, sublingual, bioequivalence

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.

Interventions

DRUGalprazolam commercial sublingual formulation

0.5 mg tablet, single dose

DRUGalprazolam test sublingual tablet

0.5 mg tablet, single dose

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 or female subjects * BMI 18 to 26.9 * must give informed consent

Exclusion criteria

* clinically significant disease * narrow angle glaucoma * positive drug screen

Design outcomes

Primary

Measure	Time frame
Alprazolam bioavailability as assessed from the area under the concentration-time curve (AUC)	11 days
Alprazolam bioavailability as assessed by peak concentration (Cmax)	11 days

Secondary

Measure	Time frame
Clinically significant safety laboratory tests	11 days
Alprazolam time of maximum concentration (Tmax)	11 days
Clinically significant vital signs	11 days
Clinically significant adverse events	11 days
Half life of alprazolam	11 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026