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Last Updated: January 20, 2025

CLINICAL TRIALS PROFILE FOR IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE


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All Clinical Trials for Ibuprofen; Pseudoephedrine Hydrochloride

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
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.
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.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 7 of 7 entries

Clinical Trial Conditions for Ibuprofen; Pseudoephedrine Hydrochloride

Condition Name

3111000.511.522.53HealthyEnuresisFeverHealthy Volunteers[disabled in preview]
Condition Name for Ibuprofen; Pseudoephedrine Hydrochloride
Intervention Trials
Healthy 3
Enuresis 1
Fever 1
Healthy Volunteers 1
[disabled in preview] 0
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Condition MeSH

11110-0.100.10.20.30.40.50.60.70.80.911.1EnuresisHeadacheBack PainAcute Pain[disabled in preview]
Condition MeSH for Ibuprofen; Pseudoephedrine Hydrochloride
Intervention Trials
Enuresis 1
Headache 1
Back Pain 1
Acute Pain 1
[disabled in preview] 0
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Clinical Trial Locations for Ibuprofen; Pseudoephedrine Hydrochloride

Trials by Country

+
Trials by Country for Ibuprofen; Pseudoephedrine Hydrochloride
Location Trials
India 2
South Africa 1
Germany 1
Canada 1
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Clinical Trial Progress for Ibuprofen; Pseudoephedrine Hydrochloride

Clinical Trial Phase

16.7%83.3%0-0.500.511.522.533.544.555.5Phase 2Phase 1[disabled in preview]
Clinical Trial Phase for Ibuprofen; Pseudoephedrine Hydrochloride
Clinical Trial Phase Trials
Phase 2 1
Phase 1 5
[disabled in preview] 0
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Clinical Trial Status

100.0%00123456Completed[disabled in preview]
Clinical Trial Status for Ibuprofen; Pseudoephedrine Hydrochloride
Clinical Trial Phase Trials
Completed 6
[disabled in preview] 0
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Clinical Trial Sponsors for Ibuprofen; Pseudoephedrine Hydrochloride

Sponsor Name

trials000111112222Dr. Reddy's Laboratories LimitedBoehringer IngelheimJohnson & Johnson Consumer and Personal Products Worldwide[disabled in preview]
Sponsor Name for Ibuprofen; Pseudoephedrine Hydrochloride
Sponsor Trials
Dr. Reddy's Laboratories Limited 2
Boehringer Ingelheim 2
Johnson & Johnson Consumer and Personal Products Worldwide 1
[disabled in preview] 2
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Sponsor Type

85.7%14.3%00123456IndustryOther[disabled in preview]
Sponsor Type for Ibuprofen; Pseudoephedrine Hydrochloride
Sponsor Trials
Industry 6
Other 1
[disabled in preview] 0
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Ibuprofen and Pseudoephedrine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Ibuprofen and pseudoephedrine hydrochloride are commonly used in combination to treat various symptoms associated with the common cold, flu, and other respiratory conditions. This article will delve into the current clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials Overview

Current Studies

Several clinical trials have been conducted or are ongoing to evaluate the efficacy and safety of ibuprofen and pseudoephedrine hydrochloride combinations.

  • Nighttime Bedwetting Study: A Phase 2 clinical trial sponsored by Johnson & Johnson aimed to determine if the combination of ibuprofen and pseudoephedrine HCl is more effective than each drug alone in treating nighttime bedwetting in children. The study involved four treatment groups and measured the mean reduction in wet nights over a 14-day treatment period[1].

  • Common Cold Symptoms: A study published in the International Journal of Clinical Practice explored the factors affecting the efficacy of an over-the-counter ibuprofen/pseudoephedrine combination in treating common cold symptoms. The study found that the combination was most effective when started within the first two days of symptom onset and that taking two tablets at the first dosing was more effective than taking one[3].

  • Bioequivalence Studies: Various bioequivalence studies have been conducted to compare different formulations of ibuprofen and pseudoephedrine hydrochloride. For example, a Phase 1 study aimed to establish the bioequivalence of a fixed-dose combination of ibuprofen and pseudoephedrine hydrochloride[4].

Mechanism of Action

Ibuprofen

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that works by inhibiting cyclooxygenase (COX) enzymes, which are involved in the production of prostaglandins. Prostaglandins are mediators of pain, inflammation, and fever. By reducing prostaglandin levels, ibuprofen provides relief from headache, fever, and minor body aches and pains[5].

Pseudoephedrine Hydrochloride

Pseudoephedrine is an α-adrenergic receptor agonist that acts as a nasal decongestant. It works by reducing the swelling of nasal passages and sinuses, thereby relieving nasal congestion and sinus pressure[5].

Market Analysis

Indications and Clinical Use

Ibuprofen and pseudoephedrine hydrochloride combinations are widely used for the temporary relief of symptoms associated with the common cold, flu, and other respiratory conditions. These symptoms include nasal congestion, headache, fever, and minor body aches and pains. The combination is available in various formulations such as tablets, caplets, and oral suspensions[5].

Market Size and Growth

The market for over-the-counter (OTC) cold and flu medications is substantial and continues to grow. The global OTC cold and flu market is driven by increasing consumer awareness, the rising prevalence of respiratory infections, and the convenience of self-medication. The combination of ibuprofen and pseudoephedrine hydrochloride is a popular choice among consumers due to its broad spectrum of action against multiple symptoms[4].

Competitive Landscape

The market for cold and flu medications is highly competitive, with several major pharmaceutical companies offering similar products. Johnson & Johnson, Pfizer, and GlaxoSmithKline are some of the key players in this market. The competition is driven by product innovation, marketing strategies, and regulatory approvals[4].

Safety and Adverse Reactions

Common Adverse Reactions

The combination of ibuprofen and pseudoephedrine hydrochloride can cause several adverse reactions. Common side effects include gastrointestinal issues such as dyspepsia and stomach pain, as well as cardiovascular effects like increased blood pressure and heart rate. Pseudoephedrine can also cause arrhythmias and has the potential for drug dependency and withdrawal effects[5].

Serious Adverse Reactions

Serious adverse reactions can include gastrointestinal tract ulceration and bleeding, which are more likely in patients with a history of peptic ulcer or other inflammatory diseases of the gastrointestinal tract. Ischemic colitis has also been reported in association with pseudoephedrine use[5].

Regulatory Status

Approvals and Indications

Ibuprofen and pseudoephedrine hydrochloride combinations have been approved for use in various countries, including the United States, where they were first approved on September 19, 1989. These products are indicated for the temporary relief of symptoms associated with the common cold, flu, and nasal congestion[4].

Regulatory Considerations

The use of pseudoephedrine is regulated in some countries due to its potential for misuse in the production of methamphetamine. Additionally, the combination must be used with caution in certain patient populations, such as those with hypertension or gastrointestinal issues, due to the potential for adverse reactions[5].

Market Projections

Future Trends

The demand for OTC cold and flu medications is expected to continue growing due to increasing consumer preference for self-medication and the rising prevalence of respiratory infections. The market is likely to see innovations in formulation and delivery systems, such as extended-release tablets and combination products with other active ingredients.

Emerging Markets

Emerging markets, particularly in Asia and Latin America, are expected to drive growth in the OTC cold and flu market. These regions have large populations and increasing disposable incomes, which are driving the demand for convenient and effective OTC medications.

Key Takeaways

  • Clinical Trials: Ongoing and completed clinical trials have demonstrated the efficacy and safety of ibuprofen and pseudoephedrine hydrochloride combinations in treating various symptoms.
  • Mechanism of Action: Ibuprofen and pseudoephedrine work through different mechanisms to provide relief from multiple symptoms associated with the common cold and flu.
  • Market Analysis: The market for OTC cold and flu medications is substantial and growing, driven by consumer awareness and the convenience of self-medication.
  • Safety and Adverse Reactions: The combination can cause common and serious adverse reactions, necessitating careful use and monitoring.
  • Regulatory Status: The products are approved in various countries but are subject to regulatory considerations due to potential misuse and adverse reactions.
  • Market Projections: The market is expected to grow driven by innovations, emerging markets, and increasing consumer demand.

FAQs

Q: What are the common indications for ibuprofen and pseudoephedrine hydrochloride combinations?

A: These combinations are indicated for the temporary relief of symptoms associated with the common cold, flu, including nasal congestion, headache, fever, and minor body aches and pains.

Q: What are the potential adverse reactions of ibuprofen and pseudoephedrine hydrochloride?

A: Common adverse reactions include gastrointestinal issues, increased blood pressure, and heart rate. Serious reactions can include gastrointestinal tract ulceration and bleeding, and ischemic colitis.

Q: Are there any regulatory restrictions on the use of pseudoephedrine?

A: Yes, pseudoephedrine is regulated in some countries due to its potential for misuse in the production of methamphetamine.

Q: What are the future trends in the market for OTC cold and flu medications?

A: The market is expected to see innovations in formulation and delivery systems, and growth driven by emerging markets and increasing consumer demand.

Q: Can ibuprofen and pseudoephedrine hydrochloride combinations be used in children?

A: Yes, but with caution and under medical supervision. A clinical trial has been conducted to evaluate the efficacy and safety of this combination in treating nighttime bedwetting in children[1].

Sources

  1. Lake Clinical Trial: A Study to Determine if Ibuprofen in Combination With Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime Bedwetting.
  2. DailyMed: IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE tablet.
  3. PubMed: Factors associated with efficacy of an ibuprofen/pseudoephedrine combination product.
  4. Patsnap Synapse: Ibuprofen/Pseudoephedrine Hydrochloride.
  5. Health Canada: Ibuprofen + Pseudoephedrine Caplets.

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