Drug: Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets Temmler Werke GmbH/ Part of Aenova Group, Germany, Intervention: one tablet administered after an overnight fast of at least 10 hours

Active Comparator: RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets Wyeth Santé Familiale, France, Intervention: one tablet administered after an overnight fast of at least 10 hours

Pain, Head

Pain, Acute

Pain, Back

Fever

Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets

RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets

Pharma Medica Research Inc.

Single-Dose Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride Tablets

A Single-Dose, Comparative Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride 200 mg/30 mg Tablets Under Fasting Conditions

The 90% confidence intervals of the relative mean plasma (1S,2S)- pseudoephedrine and (S) ibuprofen AUC should be between 80.00 and 125.00%

The 90% confidence intervals of the relative mean plasma (1S,2S)- pseudoephedrine and (S) ibuprofen Cmax should be between 80.00 and 125.00%

Institut für Pharmakologie und Präventive Medizin

Pharma Medica Research, Inc.

open-label, single-dose, randomized, two-period, two-treatment, twosequence, crossover, comparative bioavailability study.

oxymetazoline 0.05% solution intranasal spray

Middle Ear Disease

Nasal Allergy

ragweed

histamine

pseudoephedrine

Oxymetazoline

Middle Ear Physiology Laboratory, University of PIttsburgh

TransMEM Gas Exchange -- Project 1, Aim 2

Middle Ear Pressure Regulation in Health and Disease -- Gas Supply, Demand and Middle Ear Gas Balance -- Specific Aim 2

The transMEM N2O exchange constant is the primary outcome measure and is calculated as the slope of the line relating middle-ear pressure to time (until an observable active or passive ET opening) divided by the estimated extant N2O gradient.

Cuneyt M. Alper

Professor of Otolaryngology

National Institute on Deafness and Other Communication Disorders (NIDCD)

Fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).

Nasal Congestion

Cough

fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).

Group 1

Group 2

Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine + Pseudoephedrine + Dropropizine in the Control of Cough and the Relief of Nasal Symptoms, Suffering From Non-productive Cough and Acute Rhinitis

Multicenter Clinical Trial Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine + Pseudoephedrine + Dropropizine in the Control of Cough and the Relief of Nasal Symptoms in Subjects Above 12 Years of Age, Suffering From Non-productive Cough and Acute Rhinitis.

The changes of lung function parameter: pre-bronchodilator forced expiratory volume in first second (FEV1) including baseline and 24th week.

Changes in forced expiratory volume in first second (FEV1).

Ache Laboratorios Farmaceuticos S.A.

Single-dose of JNJ-39220675 will be administered as 1 milliliter (ml) of 10 milligram/milliliter (mg/ml) solution orally along with placebo tablet in first treatment period; after that in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with 60 milligram (mg) pseudoephedrine tablet; and then single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.

Single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet in first treatment period; after that, in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with placebo tablet; and then single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.

Single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in first treatment period; after that, in second treatment period, single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet; and then single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.

Single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in first treatment period; after that, in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet; and then single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.

Single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in first treatment period; after that, in second treatment period, single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution along with placebo tablet; and then single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.

Single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in first treatment period; after that, in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with placebo tablet; and then single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.

Includes all participants randomized in the study.

Entire Study Population

Sex: Female, Male

The AcR was an objective measurement of nasal congestion that assessed nasal cavity geometry (that is, MCA) and changes in dimensions of nasal cavity. The AUC of MCA was used as response variable to assess treatment effect. AUC was adjusted for Baseline MCA scores. Baseline MCA was defined as minimum mean MCA at pre-dose (approximately 2 hours before Environmental Exposure Chamber [EEC] entry) resulting from 3 measurements on both, left and right nostrils in each of the treatment periods. The AUC of MCA was baseline-adjusted, by subtracting the Baseline value from each of the post-treatment times before calculating the AUC.

Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.

Placebo

Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.

JNJ-39220675

Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.

Pseudoephedrine

Baseline Adjusted Area Under the Curve (AUC) of Minimal Cross-Sectional Area (MCA) of Nasal Cavity by Acoustic Rhinometry

The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. The AUC of TNSS was used as response variable to assess the treatment effect. AUC was adjusted for Baseline TNSS scores. Baseline TNSS was defined as the symptom scores for each treatment period at pre-dose (approximately 2 hour before EEC entry).

Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS)

The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. Change from Baseline in TNSS is the value at particular time point minus value at Baseline.

Change From Baseline in Total Nasal Symptom Score (TNSS) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 Hours After Drug Administration at Day 1

The MCA was measured using AcR which is an objective measurement of nasal congestion that assesses nasal cavity geometry (that is, MCA) and changes in the dimensions of the nasal cavity. Change from Baseline in MCA is the value at particular time point minus value at Baseline.

Change From Baseline in Minimal Cross-Sectional Area (MCA) at 1, 2, 3, 4, 5, 6, 7 and 8 Hours After Drug Administration at Day 1

Single-dose of JNJ-39220675 as 1 milliliter (ml) of 10 milligram/milliliter (mg/ml) solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and 60 milligram (mg) pseudoephedrine tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.

JNJ-39220675 Then Pseudoephedrine Then Placebo

Single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.

JNJ-39220675 Then Placebo Then Pseudoephedrine

Single-dose of 1 ml placebo solution orally and placebo tablet orally in first treatment period; after that single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.

Placebo Then JNJ-39220675 Then Pseudoephedrine

Single-dose of 1 ml placebo solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in second treatment period; and then single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.

Placebo Then Pseudoephedrine Then JNJ-39220675

Single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in first treatment period; after that single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.

Pseudoephedrine Then JNJ-39220675 Then Placebo

Single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and placebo tablet orally in second treatment period; and then single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.

Pseudoephedrine Then Placebo Then JNJ-39220675

Period 1: Treatment Period

Period 2: Washout Period

Period 3: Treatment Period

Period 4: Washout Period

Period 5: Treatment Period

Senior Medical Director

Allergic Rhinitis

Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.

Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.

Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.

An Efficacy Study of JNJ-39220675 and Pseudoephedrine in Participants With Allergic Rhinitis

A Randomized, Single-Dose, Single-Blind, Double-Dummy, Placebo-Controlled, Three-Way Cross-Over Study to Compare the Relative Efficacy of JNJ-39220675, Pseudoephedrine and Placebo for the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Model

pseudoephedrine/radang

Single-Dose Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride Tablets

TransMEM Gas Exchange -- Project 1, Aim 2

Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine + Pseudoephedrine + Dropropizine in the Control of Cough and the Relief of Nasal Symptoms, Suffering From Non-productive Cough and Acute Rhinitis

An Efficacy Study of JNJ-39220675 and Pseudoephedrine in Participants With Allergic Rhinitis

Preventing Frequent Sinus Infections in HIV-Infected Patients

Database tanaman obat terlengkap yang didukung oleh sains