MedTrace Logo

Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions

NCT00878514 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2009-11-25

No results posted yet for this study

Summary

The objective of the study is to demonstrate the bioequivalence (BE) of alprazolam 1 mg tablet with Xanax® 1 mg tablet under fed conditions.

Conditions

  • Healthy

Interventions

DRUG

Alprazolam

Alprazolam 1 mg tablet

DRUG

Xanax

Xanax 1 mg tablet

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Aila Holopainen, M.Sc. · Orion Corporation, Orion Pharma

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-06-30
Completion
2009-07-31

Countries

  • Finland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00878514 on ClinicalTrials.gov