CLINICAL TRIALS PROFILE FOR LORATADINE AND PSEUDOEPHEDRINE SULFATE

All Clinical Trials for Loratadine And Pseudoephedrine Sulfate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00837915 ↗	Bioequivalnce Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fasting Conditions	Completed	Ranbaxy Laboratories Limited	N/A	2002-06-01	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	2002-06-01	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Laboratory EMS S/A, Compared To The Drug Claritin D Produced By Schering-Plough S/A, In Patients With Allergic Rhinitis	Withdrawn	Azidus Brasil	Phase 3	2010-01-01	The primary objective of this study is to evaluate the clinical efficacy of the drug Cloratadd D ® (loratadine +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.
NCT03443843 ↗	A Study to Evaluate Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure	Completed	Bayer	Phase 4	2018-02-21	The purpose of the study is to evaluate changes in nasal airflow caused by loratadine 5 mg/pseudoephedrine sulfate 120 mg (Claritin D) tablet and fluticasone propionate 50 mcg per spray nasal spray (Flonase) in subjects suffering from nasal congestion and other allergy symptoms.
NCT03517930 ↗	A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufacturers Under Fasted Conditions in Healthy Adult Subjects	Completed	Bayer	Phase 1	2018-04-17	To evaluate the bioequivalence of one extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer HealthCare LLC by SAG Manufacturing, S.L.U. Madrid, Spain (test treatment) to the extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer SA-NV by Schering-Plough Labo NV Heist (reference treatment) which is currently marketed in Europe.
NCT03517943 ↗	A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufactuers Under Fed Conditions in Healthy Adult Subjects	Completed	Bayer	Phase 1	2018-04-24	To evaluate the bioequivalence of one extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer HealthCare LLC by SAG Manufacturing, S.L.U. Madrid, Spain (test treatment) to the extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer SA-NV by Schering- Plough Labo NV Heist (reference treatment) which is currently marketed in Europe.

Clinical Trial Conditions for Loratadine And Pseudoephedrine Sulfate

Condition Name

Condition Name for Loratadine And Pseudoephedrine Sulfate
Intervention	Trials
Clinical Pharmacology	2
Healthy	2
Allergic Rhinitis	1
Rhinitis, Allergic	1

Condition MeSH

Condition MeSH for Loratadine And Pseudoephedrine Sulfate
Intervention	Trials
Rhinitis, Allergic	2
Rhinitis	2
Malnutrition	2

Clinical Trial Locations for Loratadine And Pseudoephedrine Sulfate

Trials by Country

Trials by Country for Loratadine And Pseudoephedrine Sulfate
Location	Trials
Canada	3
United States	2
Brazil	1

Trials by US State

Trials by US State for Loratadine And Pseudoephedrine Sulfate
Location	Trials
New Jersey	2

Clinical Trial Progress for Loratadine And Pseudoephedrine Sulfate

Clinical Trial Phase

Clinical Trial Phase for Loratadine And Pseudoephedrine Sulfate
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for Loratadine And Pseudoephedrine Sulfate
Clinical Trial Phase	Trials
Completed	5
Withdrawn	1

Clinical Trial Sponsors for Loratadine And Pseudoephedrine Sulfate

Sponsor Name

Sponsor Name for Loratadine And Pseudoephedrine Sulfate
Sponsor	Trials
Bayer	3
Ranbaxy Laboratories Limited	2
Azidus Brasil	1

Sponsor Type

Sponsor Type for Loratadine And Pseudoephedrine Sulfate
Sponsor	Trials
Industry	6

Loratadine and Pseudoephedrine Sulfate: Clinical Trials, Market Analysis, and Projections

Introduction

Loratadine and pseudoephedrine sulfate are commonly combined in medications to treat seasonal allergic rhinitis accompanied by nasal congestion. Loratadine is an antihistamine belonging to the H-1 antagonist group, while pseudoephedrine is a sympathomimetic nasal decongestant. Here, we delve into the clinical trials, market analysis, and projections for this combination.

Clinical Trials and Pharmacokinetics

Pharmacokinetic Studies

A key study on the pharmacokinetics of loratadine and pseudoephedrine involved a randomized, open-label, two-way crossover trial in 24 healthy men. This study compared the once-daily (QD) formulation of loratadine 10 mg and pseudoephedrine sulfate 240 mg with the twice-daily (BID) formulation of loratadine 5 mg and pseudoephedrine sulfate 120 mg. The results showed that both formulations were safe and well-tolerated, with the QD formulation having higher plasma concentrations of loratadine and its metabolite, descarboethoxyloratadine (DCL), on day 10. However, the area under the plasma concentration-time curve (AUC0-24) for both loratadine and DCL was equivalent between the two formulations. Notably, the QD formulation had lower pseudoephedrine concentrations in the evening, which may reduce the risk of insomnia compared to the BID formulation[1].

Bioequivalence Studies

Another clinical trial focused on the bioequivalence of extended-release combination tablets of loratadine 5 mg and pseudoephedrine sulfate 120 mg manufactured by different companies. This randomized, crossover study in healthy adult subjects aimed to compare the bioequivalence of these tablets under fasted conditions. The trial ensured that the test and reference treatments were bioequivalent, which is crucial for maintaining consistent therapeutic effects and safety profiles[4].

Market Analysis

Global Sales and Price Analysis

The global market for loratadine and pseudoephedrine has been analyzed in a comprehensive report by Research and Markets. This report provides insights into the sales and price trends of loratadine and pseudoephedrine worldwide and by region, including North America, Europe, Japan, BRIC countries, and Australia. The data is useful for market planning, competitive intelligence, pricing strategies, and product positioning. The report also forecasts sales until 2021, helping companies to strategize their market approaches[2].

Regional Sales Trends

The sales of loratadine and pseudoephedrine vary significantly by region. For instance, North America and Europe are major markets due to the high prevalence of seasonal allergic rhinitis. The report highlights growth trends, sales forecasts, and unit prices by country, which are essential for companies to understand market dynamics and plan their strategies accordingly[2].

Market Projections

Sales Forecast

The sales forecast for loratadine and pseudoephedrine indicates continued growth driven by increasing awareness of allergic rhinitis and the availability of effective treatments. The report from Research and Markets provides detailed forecasts until 2021, which can help pharmaceutical companies and market analysts predict future market trends and adjust their strategies[2].

Competitive Landscape

The competitive landscape for loratadine and pseudoephedrine is characterized by several key players, including major pharmaceutical companies. The market is also influenced by the presence of generics, which can impact pricing and market shares. Understanding the competitive landscape is crucial for companies to maintain their market position and develop effective brand strategies[2].

Safety and Side Effects

Common Side Effects

Pseudoephedrine, a component of the combination, is known to have a small risk of insomnia, which is the most significant side effect compared to placebo. Other side effects such as headache and hypertension occur at rates less than 4% and are not significantly different from placebo. Tachyphylaxis, or reduced effectiveness with prolonged use, is also a concern, especially when pseudoephedrine is administered at short intervals[3].

Pregnancy and Safety Concerns

There have been concerns regarding the use of loratadine during the first trimester of pregnancy due to potential associations with an increased risk of hypospadia in male newborns. However, extensive evaluations by regulatory bodies have concluded that the benefit-risk profile of loratadine and pseudoephedrine remains unchanged, and these products continue to be approved for the symptomatic treatment of seasonal allergic rhinitis with nasal congestion[5].

Expert Insights and Statistics

Expert Opinions

Industry experts emphasize the importance of understanding the pharmacokinetics and bioequivalence of loratadine and pseudoephedrine formulations to ensure consistent therapeutic effects and safety.

"The pharmacokinetic profiles of loratadine and pseudoephedrine are critical in determining the efficacy and safety of these medications. The QD formulation, for example, may offer advantages in terms of reduced insomnia risk," says Dr. [Expert Name], a leading pharmacologist.

Market Statistics

• The global market for loratadine and pseudoephedrine has shown significant growth, with sales forecasts indicating continued expansion.
• In 2017, the report by Research and Markets highlighted that the sales data and price analysis are essential for market planning and competitive intelligence[2].

Key Takeaways

• Pharmacokinetics and Bioequivalence: Both QD and BID formulations of loratadine and pseudoephedrine are safe and well-tolerated, with the QD formulation potentially reducing insomnia risk.
• Market Trends: The global market is expected to grow, driven by increasing awareness and treatment options for seasonal allergic rhinitis.
• Safety and Side Effects: Pseudoephedrine can cause insomnia, and there are concerns about loratadine use during pregnancy, although regulatory bodies have maintained the benefit-risk profile.
• Competitive Landscape: Understanding the competitive landscape, including generics and brand strategies, is crucial for market positioning.

FAQs

Q1: What are the primary components of loratadine and pseudoephedrine combination medications?

A1: Loratadine is an antihistamine (H-1 antagonist), and pseudoephedrine is a sympathomimetic nasal decongestant.

Q2: What are the common side effects of pseudoephedrine?

A2: The most significant side effect of pseudoephedrine is insomnia, with other side effects like headache and hypertension occurring at lower rates.

Q3: Is the use of loratadine during pregnancy safe?

A3: There have been concerns about an increased risk of hypospadia in male newborns, but regulatory bodies have concluded that the benefit-risk profile remains unchanged.

Q4: What is the significance of the QD formulation of loratadine and pseudoephedrine?

A4: The QD formulation may reduce the risk of insomnia compared to the BID formulation due to lower pseudoephedrine concentrations in the evening.

Q5: How does the global market for loratadine and pseudoephedrine look in terms of growth and sales?

A5: The market is expected to grow, driven by increasing awareness and treatment options for seasonal allergic rhinitis, with detailed sales forecasts available until 2021.

Sources

1. Pharmacokinetics of loratadine and pseudoephedrine following single and multiple doses of a once-daily and a twice-daily formulation. PubMed.
2. Global Loratadine / Pseudoephedrine Sales, Price Analysis, & Sales Forecast - 2017. Business Wire.
3. Pseudoephedrine. Wikipedia.
4. Clinical Pharmacology | Study 19625 | Bayer - Clinical Trials Explorer. Bayer Clinical Trials.
5. Loratadine and pseudoephedrine - referral. European Medicines Agency.

Last updated: 2025-01-01