Bioequivalence of Alprazolam Sublingual vs Oral Tablets

Open-Label, Randomized, Single-Dose, 2-Way Crossover Pivotal Bioequivalence Study Comparing Alprazolam Immediate Release (IR) Tablets (Administered Orally) And Alprazolam Sublingual (SL) Tablets (Administered Sublingually)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00860119

Enrollment

Registered

2009-03-11

Start date

2009-08-31

Completion date

2009-10-31

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

Bioequivalence, Pharmacokinetics, Alprazolam, Sublingual

Brief summary

This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from a standard orally administered tablet.

Interventions

DRUGalprazolam sublingual tablet

1 mg alprazolam sublingual tablet, given as a single dose to each subject

DRUGalprazolam oral tablet

1 mg alprazolam immediate release oral tablet, given as a single dose to each subject

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male or female subjects * BMI 17.5 - 30.5 * Must provide informed consent

Exclusion criteria

* Clinically significant disease * Narrow angle glaucoma * Positive drug screen

Design outcomes

Primary

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

Secondary

Measure	Time frame
Alprazolam time of maximum concentration (Tmax) and half life	11 days
Adverse events, clinical laboratory tests, vital signs	11 days

Countries

India

Outcome results

None listed

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