NCT00810316

Evaluate Pharmacokinetics Of Two Different Pharmaceutical Oral Formulations Of Alprazolam And A Clonazepam Tablet In Mexican Healthy Population

Evaluate The Pharmacokinetics Of Two Alprazolam Formulations (Immediate Release And Extended Release Tablets) And A Clonazepam Tablet In A Healthy Mexican Population

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To estimate the pharmacokinetics of single doses of benzodiazepines in Mexican adult healthy volunteers: a) alprazolam tablet extended release, b) alprazolam tablet immediate release, and clonazepam tablet.

Detailed description

To determine pharmacokinetics of alprazolam and clonazepam in Latin-American population; in Mexico, both drugs are still widely used as first or second choice in the treatment of anxiety disorders.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Alprazolam	Administration of a single oral dose tablet of 1 mg of alprazolam immediate release on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions
DRUG	Alprazolam XR	Administration of a single oral dose tablet of 1 mg of alprazolam modified release on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions
DRUG	Clonazepam	Administration of a single oral dose of two tablets of 0.5 mg of clonazepam on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions

Timeline

• Start date: 2008-10-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2008-12-18
• Last updated: 2021-01-28

Locations

1 site across 1 country: Mexico