drugset / Trial / NCT00932256

Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients

NCT00932256

Phase 1 Completed 21 enrolled Magna Pharmaceuticals, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

MAGNA intends to show that the combination of pseudoephedrine, chlorpheniramine, plus a small amount of belladonna alkaloid is a comprehensive, safe and effective twice daily (BID) drug treatment for seasonal allergic rhinitis (SAR) patients with post-nasal drip (PND). The phase 1 single-dose trial will consist of 21 subjects: 1) to gather pharmacodynamic measurements and blood levels of active ingredients over 12 hours; 2) To report subjective scores by subjects rating efficacy of single dose of STAHIST; 3) To report any side effects or adverse drug reactions and rate the severity of incidence.

Timeline

Start
2009-10
Primary completion
2009-10
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Atropine Other / unclassified 0.24 mg Oral
Subject Chlorpheniramine Unknown 8 mg Oral
Subject Pseudoephedrine Small molecule 90 mg Oral