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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR PSEUDOEPHEDRINE SULFATE

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Clinical Trials for Pseudoephedrine Sulfate

Trial ID Title Status Sponsor Phase Summary
NCT00837915 Bioequivalnce Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fasting Conditions Completed Ranbaxy Laboratories Limited N/A The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets, in a fully replicated design, under fasting conditions.
NCT00845546 Bioequivalence Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fed Conditions Completed Ranbaxy Laboratories Limited N/A The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin-D® 24 hour) 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets, in a fully replicated design, under fed conditions.
NCT01055756 Clinical Trial Of The Effectiveness Of The Product Cloratadd D (Loratadine + Pseudoephedrine Sulfate) Produced By The Laboratory EMS S/A, Compared To The Drug Claritin D Produced By Schering-Plough S/A, In Patients With Allergic Rhinitis Withdrawn Azidus Brasil Phase 3 The primary objective of this study is to evaluate the clinical efficacy of the drug Cloratadd D ® (loratadine + pseudoephedrine sulfate - EMS S/A) compared to the drug Claritin D ® (loratadine + pseudoephedrine sulfate - Schering Plough) in patients with allergic rhinitis by quantification of the scores of clinical parameters (signs and symptoms) and laboratory (nasal flow) down through time.
NCT01293201 Trial of STAHIST in Seasonal Allergic Rhinitis Completed Magna Pharmaceuticals, Inc. Phase 3 The overall development plan is to show that the combination of tried-and-proven decongestant/antihistamine ingredients (pseudoephedrine hydrochloride and chlorpheniramine maleate), plus a very small amount of belladonna alkaloids (.24 mg atropine sulfate) is a comprehensive, safe and effective B.I.D. drug treatment regimen, indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Treated symptoms include nasal congestion, sneezing, rhinorrhea, itchy nose, itchy/watery eyes, and post nasal drip syndrome [reduction in tickly cough (acute or chronic), mucus in the back of the throat, sore throat, and hoarseness]. Considering the favorable safety and efficacy results of Phase 1 and Phase 2, the purpose of Phase 3 is to assess and compare the safety and efficacy of the study drug in a larger group comparatively with a placebo control group. Objectives: A) To report and compare total symptom scores (TSS) by SAR subjects rating the efficacy of STAHIST vs. placebo in relieving nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over the two-week study period. B) Report any side effects or adverse drug reactions and rate the severity of any incident. C) Compare and report each symptom score, total nasal symptom scores (TNSS), and post-nasal drip symptom scores (PND-S) between the two study arms.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Pseudoephedrine Sulfate

Condition Name

Condition Name for Pseudoephedrine Sulfate
Intervention Trials
Healthy 3
Clinical Pharmacology 2
Seasonal Allergic Rhinitis 1
Rhinitis, Allergic 1
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Condition MeSH

Condition MeSH for Pseudoephedrine Sulfate
Intervention Trials
Rhinitis, Allergic 3
Rhinitis 3
Rhinitis, Allergic, Seasonal 1
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Clinical Trial Locations for Pseudoephedrine Sulfate

Trials by Country

Trials by Country for Pseudoephedrine Sulfate
Location Trials
United States 8
Canada 4
Brazil 1
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Trials by US State

Trials by US State for Pseudoephedrine Sulfate
Location Trials
New Jersey 2
Texas 1
South Carolina 1
Ohio 1
Kentucky 1
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Clinical Trial Progress for Pseudoephedrine Sulfate

Clinical Trial Phase

Clinical Trial Phase for Pseudoephedrine Sulfate
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for Pseudoephedrine Sulfate
Clinical Trial Phase Trials
Completed 7
Withdrawn 1
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Clinical Trial Sponsors for Pseudoephedrine Sulfate

Sponsor Name

Sponsor Name for Pseudoephedrine Sulfate
Sponsor Trials
Bayer 3
Ranbaxy Laboratories Limited 2
Magna Pharmaceuticals, Inc. 1
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Sponsor Type

Sponsor Type for Pseudoephedrine Sulfate
Sponsor Trials
Industry 8
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Serving hundreds of leading biopharmaceutical companies globally:

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