NCT00878865

Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets

Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets; an Open, Randomised, Single Centre, Single Dose Study With Crossover Design in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of the study is to demonstrate the bioequivalence (BE) of two alprazolam 1 mg tablets.

Detailed description

The study is a phase I, open, randomised, crossover, single dose pharmacokinetic study performed in a single centre. The study consists of 2 treatment periods, during which the study subjects will receive the test product and the reference product in a randomised order. During both treatment periods, the study subjects will receive 1 mg of alprazolam as a single oral dose. The study treatments will be administered after an overnight fast (at least 10 h). Blood samples will be drawn during both treatment periods. The planned duration of the study per subject will be 4-5 weeks including a screening visit, 2 treatment periods with a wash-out between the study treatment administrations and a post-treatment period.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Alprazolam	1 mg tablet one oral dose
DRUG	Alprazolam	1 mg tablet

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2009-04-09
• Last updated: 2009-11-25

Locations

1 site across 1 country: Finland