Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet

Viatris

Status and phase: Completed; Phase 1

Conditions: Anxiety Disorder

Treatments: Drug: Alprazolam sublingual; Drug: Alprazolam tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01256151

A6131024

Details and patient eligibility

About

To assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam.

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

28 participants in 2 patient groups

Alprazolam conventional tablet

Active Comparator group

Description:

Alprazolam conventional tablet

Treatment:

Drug: Alprazolam tablet

Alprazolam sublingual tablet

Experimental group

Description:

Alprazolam sublingual tablet

Treatment:

Drug: Alprazolam sublingual