CLINICAL TRIALS PROFILE FOR IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

All Clinical Trials for Ibuprofen And Pseudoephedrine Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00240812 ↗	A Study to Determine if Ibuprofen in Combination With Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime Bedwetting	Completed	Johnson & Johnson Consumer and Personal Products Worldwide	Phase 2	1969-12-31	The purpose of the study is to determine if ibuprofen in combination with pseudoephedrine HCl in the treatment of nightime bedwetting in children is more effective than each drug alone and if the individual drugs are more effective than placebo.
NCT01131780 ↗	Bioequivalency Study of Ibuprofen 200 mg and Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's Under Fasting Conditions	Completed	Dr. Reddy's Laboratories Limited	Phase 1	2004-10-01	The purpose of this study is to assess the bioequivalence of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg under fasting conditions.
NCT01132222 ↗	Bioequivalence Study of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets Under Fed Conditions	Completed	Dr. Reddy's Laboratories Limited	Phase 1	2004-09-01	The purpose of this study is to assess the bioequivalence of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg under fed conditions.
NCT01170637 ↗	Bioequivalence of a Fixed Dose Combination Tablet Containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl Compared to RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a Fixed Dose Combination Tablet Administered in Healthy Volunteer	Completed	Boehringer Ingelheim	Phase 1	2010-07-01	The objective of the current study is to demonstrate bioequivalence of a fixed dose combination tablet containing ibuprofen 200 mg and pseudoephedrine-HCl 30 mg (Test) and RhinAdvil® (Reference) a fixed dose combination tablet containing ibuprofen 200 mg and pseudoephedrine-HCl 30 mg following orally administration.
NCT02963701 ↗	Bioequivalence of a Fixed Dose Combination Tablet Containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl Compared to Two Film Coated Fixed Dose Combination Tablets RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in Healt	Completed	Boehringer Ingelheim	Phase 1	2016-12-20	Primary objective To demonstrate the bioequivalence of a fixed dose combination tablet containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl vs. RhinAdvil® (2 tablets containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a fixed dose combination tablet with respect to the analytes, ibuprofen and pseudoephedrine. Secondary objective To assess the bioequivalence of a fixed dose combination tablet containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl vs. RhinAdvil® (2 tablets containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a fixed dose combination tablet with respect to R- and S-ibuprofen (enantiomers of ibuprofen).
NCT03429738 ↗	Single-Dose Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride Tablets	Completed	Pharma Medica Research, Inc.	Phase 1	2014-04-27	Evaluation of the comparative bioavailability between two oral formulations containing ibuprofen 200 mg and pseudoephedrine 30 mg after a single dose in healthy subjects under fasting conditions.
NCT03429738 ↗	Single-Dose Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride Tablets	Completed	Institut für Pharmakologie und Präventive Medizin	Phase 1	2014-04-27	Evaluation of the comparative bioavailability between two oral formulations containing ibuprofen 200 mg and pseudoephedrine 30 mg after a single dose in healthy subjects under fasting conditions.

Clinical Trial Conditions for Ibuprofen And Pseudoephedrine Hydrochloride

Condition Name

Condition Name for Ibuprofen And Pseudoephedrine Hydrochloride
Intervention	Trials
Healthy	3
Pain, Head	1
Enuresis	1
Fever	1

Condition MeSH

Condition MeSH for Ibuprofen And Pseudoephedrine Hydrochloride
Intervention	Trials
Nocturnal Enuresis	1
Enuresis	1
Headache	1
Back Pain	1

Clinical Trial Locations for Ibuprofen And Pseudoephedrine Hydrochloride

Trials by Country

Trials by Country for Ibuprofen And Pseudoephedrine Hydrochloride
Location	Trials
India	2
Canada	1
South Africa	1
Germany	1

Clinical Trial Progress for Ibuprofen And Pseudoephedrine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Ibuprofen And Pseudoephedrine Hydrochloride
Clinical Trial Phase	Trials
Phase 2	1
Phase 1	5

Clinical Trial Status

Clinical Trial Status for Ibuprofen And Pseudoephedrine Hydrochloride
Clinical Trial Phase	Trials
Completed	6

Clinical Trial Sponsors for Ibuprofen And Pseudoephedrine Hydrochloride

Sponsor Name

Sponsor Name for Ibuprofen And Pseudoephedrine Hydrochloride
Sponsor	Trials
Dr. Reddy's Laboratories Limited	2
Boehringer Ingelheim	2
Johnson & Johnson Consumer and Personal Products Worldwide	1

Sponsor Type

Sponsor Type for Ibuprofen And Pseudoephedrine Hydrochloride
Sponsor	Trials
Industry	6
Other	1

Ibuprofen and Pseudoephedrine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Ibuprofen and pseudoephedrine hydrochloride are commonly used in combination to treat various symptoms, including those associated with the common cold, pain, and congestion. This article will delve into the clinical trials, market analysis, and projections for this drug combination.

Clinical Trials Overview

Treatment of Nighttime Bedwetting

A clinical trial sponsored by Johnson & Johnson Consumer and Personal Products Worldwide aimed to determine the efficacy of ibuprofen in combination with pseudoephedrine HCl in treating nighttime bedwetting in children. The study involved a double-blind, placebo-controlled, randomized design where patients were divided into four treatment groups. The primary efficacy measurement was the mean reduction in wet nights during the treatment period. The study hypothesized that the combination of ibuprofen and pseudoephedrine would have a greater effect than either drug alone or placebo[1].

Bioequivalence Studies

Another study focused on evaluating the bioequivalence of a new oral granule formulation of ibuprofen and pseudoephedrine compared to a reference market standard. This open, randomized, single-dose, two-period crossover trial demonstrated that the new formulation was bioequivalent for pseudoephedrine and provided therapeutic equivalence for ibuprofen, although it slightly exceeded the upper acceptance limit for ibuprofen's Cmax. The study concluded that the new formulation offers more convenient administration without altering the total exposure of the drugs[2].

Pharmacokinetics and Bioavailability

A single-center, randomized, single-dose, open-label, 3-period crossover study compared the pharmacokinetics of an oral suspension containing ibuprofen and pseudoephedrine with individual component suspensions. The study found that the combination suspension met the regulatory criteria for bioequivalence and was well tolerated. The pharmacokinetic parameters, such as Cmax and AUC, were comparable between the combination and individual component suspensions[4].

Market Analysis

Global Sales and Trends

The global market for ibuprofen and pseudoephedrine has shown significant growth trends. A report by Research and Markets provided a detailed analysis of sales, price, and sales forecasts until 2021. The report highlighted that the sales data and pricing analysis are crucial for market planning, competitive intelligence, and strategic forecasts. The sales of ibuprofen and pseudoephedrine vary by country, with notable markets in North America, Europe, Japan, BRIC countries, and Australia[5].

Market Forecast

The sales forecast for ibuprofen and pseudoephedrine indicates continued growth driven by increasing demand for over-the-counter (OTC) medications. The report helps in identifying key companies marketing these products, determining unit sales by country, and devising pricing strategies. This data is essential for market assessments, market sizing, and competitive intelligence[5].

Efficacy in Common Cold Symptoms

Symptom Reduction

A study exploring the factors affecting the efficacy of an ibuprofen/pseudoephedrine combination in treating common cold symptoms found that the combination was highly effective. The study analyzed data from 1770 pharmacy customers and reported significant reductions in symptom intensity, particularly for ibuprofen-sensitive symptoms like headache and fever, and pseudoephedrine-responsive symptoms like nasal congestion. Starting treatment within the first two days of the cold was associated with greater efficacy[3].

Safety and Tolerability

Clinical Trial Findings

All the clinical trials mentioned have reported that the combination of ibuprofen and pseudoephedrine is well tolerated. Safety assessments in these studies included monitoring adverse events, physical examinations, and vital signs, which showed no significant differences in safety profiles between the combination and individual components[1][2][4].

Formulation Innovations

Oral Granules and Suspensions

The development of new formulations such as oral granules and suspensions has improved the administration and flexibility of dosing for patients, especially those with dysphagia, children, and the elderly. These formulations maintain similar pharmacokinetic profiles to conventional forms, ensuring therapeutic equivalence while offering more convenient administration[2][4].

Key Takeaways

• Clinical Efficacy: The combination of ibuprofen and pseudoephedrine has shown efficacy in treating various symptoms, including nighttime bedwetting and common cold symptoms.
• Bioequivalence: New formulations of ibuprofen and pseudoephedrine have been shown to be bioequivalent to conventional forms, offering more convenient administration.
• Market Growth: The global market for ibuprofen and pseudoephedrine is expected to continue growing, driven by demand for OTC medications.
• Safety: The combination is generally well tolerated, with safety profiles comparable to individual components.
• Formulation Innovations: New formulations like oral granules and suspensions enhance patient compliance and convenience.

FAQs

Q: What is the primary use of the combination of ibuprofen and pseudoephedrine?

A: The primary use is to treat symptoms associated with the common cold, such as pain, fever, and nasal congestion, as well as other conditions like nighttime bedwetting.

Q: Have clinical trials shown the efficacy of ibuprofen and pseudoephedrine in treating nighttime bedwetting?

A: Yes, clinical trials have been conducted to evaluate the efficacy of this combination in treating nighttime bedwetting in children, though the results are still under analysis[1].

Q: What are the key findings regarding the bioequivalence of new ibuprofen and pseudoephedrine formulations?

A: New formulations have been shown to be bioequivalent to conventional forms, ensuring therapeutic equivalence and offering more convenient administration[2][4].

Q: How does the timing of treatment initiation affect the efficacy of ibuprofen and pseudoephedrine in treating common cold symptoms?

A: Starting treatment within the first two days of the cold is generally more effective than starting later[3].

Q: Are there any safety concerns associated with the combination of ibuprofen and pseudoephedrine?

A: Clinical trials have reported that the combination is well tolerated, with safety profiles similar to those of the individual components[1][2][4].

Sources

1. Lake Clinical Trial: A Study to Determine if Ibuprofen in Combination with Pseudoephedrine HCl Has a Greater Effect in the Treatment of Nighttime Bedwetting Than Either Drug Alone or Placebo.
2. American Journal of Medical and Clinical Research & Reviews: Ibuprofen and Pseudoephedrine Hydrochloride as Granules for Oral Solution.
3. International Journal of Clinical Practice: Factors Associated with Efficacy of an Ibuprofen/Pseudoephedrine Combination in the Treatment of Common Cold Symptoms.
4. Frontiers in Pharmacology: Pharmacokinetics and Bioavailability of Single Dose Ibuprofen and Pseudoephedrine Combined in a New Formulation.
5. Research and Markets: Global Ibuprofen / Pseudoephedrine Sales, Price Analysis, & Sales Forecast Report 2017-2021.