Delving into the Latest Updates on Ibuprofen/Pseudoephedrine Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Compound Ibuprofen for Suspension, Ibuprofen and Pseudoephed Hydrochloride Granules, Ibuprofen and Pseudoephedrin Hydrochloride

+ [17]

Target

COXs x α-adrenergic receptor

Action

inhibitors, agonists

Mechanism

COX inhibitors(Cyclooxygenases inhibitors), α-adrenergic receptor agonists(Alpha adrenergic receptor agonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesOtorhinolaryngologic Diseases+ [1]

Active Indication

Rhinitis, AllergicSinusitisNasal Obstruction+ [2]

Inactive Indication-

Originator Organization

Pfizer Inc.

Active Organization

Haleon US Capital LLC

Johnson & Johnson Pacific Pty Ltd.

Hebei Jiheng (Group) Pharmaceutical Co. Ltd.

+ [1]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

United States (19 Sep 1989),

Common ColdInfluenza, Human

Regulation-

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Structure/Sequence

Molecular FormulaC13H18O2

InChIKeyHEFNNWSXXWATRW-UHFFFAOYSA-N

CAS Registry15687-27-1

View All Structures (2)

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® (200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in at Least 48 Healthy Male and Female Subjects (Open-label, Randomized, Laboratory Blind, Single Dose, Two-way Crossover, Phase I Trial).

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).

Start Date20 Dec 2016

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT03184766

/ CompletedPhase 1

An Open-label, Randomised, Three-way Cross-over, Single Dose, Single Centre, Comparative Pharmacokinetic Study Between Ibuprofen and Pseudoephedrine Liquid Capsules (2x 200 mg Ibuprofen & 30 mg Pseudoephedrine) (Test), Ibuprofen and Pseudoephedrine Tablets (2x 200 mg Ibuprofen & 30 mg Pseudoephedrine) (Comparator 1), and Ibuprofen Liquid Capsules (2x 200 mg Solubilised Ibuprofen) (Comparator 2)

This comparative pharmacokinetic study is being conducted to provide supporting evidence for inclusion in dossiers to regulatory authorities for an Article 8(3) of Directive 2001/83/EC abridged application for ibuprofen and pseudoephedrine liquid capsules (200 mg ibuprofen & 30 mg pseudoephedrine).

Start Date10 Aug 2016

Sponsor / Collaborator

Reckitt Benckiser Healthcare (UK) Ltd.

[+1]

NCT02902289

/ CompletedPhase 1

Bioequivalence Study of a New Formulation of Ibuprofen 200 mg/5 mL Oral Suspension vs. the Reference Product MOMENT 200 mg Coated Tablet in Healthy Volunteers

The main objective of the study is to evaluate the bioequivalence of a new formulation of ibuprofen 200 mg/5 mL oral suspension vs. the marketed reference product MOMENT 200 mg coated tablet, when administered under fasting conditions as single oral dose to healthy male and female volunteers, in two consecutive study periods.

Start Date01 Jun 2016

Sponsor / Collaborator

Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. - SpA

[+1]

100 Clinical Results associated with Ibuprofen/Pseudoephedrine Hydrochloride

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100 Translational Medicine associated with Ibuprofen/Pseudoephedrine Hydrochloride

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100 Patents (Medical) associated with Ibuprofen/Pseudoephedrine Hydrochloride

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1

Literatures (Medical) associated with Ibuprofen/Pseudoephedrine Hydrochloride

01 Jan 1981·Veterinary and human toxicology

Radiopacity of drugs and plants in vivo-limited usefulness.

Article

Author: Jaeger, R W ; Decastro, F J ; Brodeur, A E ; Gerren, L J ; Barry, R C

100 Deals associated with Ibuprofen/Pseudoephedrine Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	R05X	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Rhinitis, Allergic	Australia	Johnson & Johnson Pacific Pty Ltd.	14 Sep 2001
Sinusitis	Australia	Johnson & Johnson Pacific Pty Ltd.	14 Sep 2001
Nasal Obstruction	China	Hebei Jiheng (Group) Pharmaceutical Co. Ltd.	01 Jan 1999
Common Cold	United States	Haleon US Capital LLC	19 Sep 1989
Influenza, Human	United States	Haleon US Capital LLC	19 Sep 1989