NCT01587027

Safety Evaluation of Aminophylline and Methazolamide

The Safety Evaluation of Aminophylline and Methazolamide When Administered Orally Alone and in Combination to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Poudre Valley Health System · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This safety study is the first in a series of studies testing the application of the combination of aminophylline and methazolamide.

Detailed description

After successful completion of this safety trial, our goal will be to evaluate the safety of this combination in healthy individuals exposed to hypoxia and exercise. Subsequently, an efficacy study will clarify whether this drug combination improves physical and mental functions in human subjects under high altitude conditions.

Conditions

• Mountain Sickness

Interventions

Type	Name	Description
DRUG	Aminophylline	Aminophylline dosage form-tablet dosage-500mg
DRUG	Methazolamide	Methazolamide dosage form-tablet dosage-250mg
DRUG	Aminophylline and Methazolamide	Aminophylline 500mg orally and Methazolamide 250mg orally

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2012-04-27
• Last updated: 2017-02-10
• Results posted: 2014-06-09

Locations

1 site across 1 country: United States