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Mucinex® ER 600 mg Bi-layer Tablet Versus Guaifenesin Immediate Release (IR) 200 mg q4h

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ClinicalTrials.gov Identifier: NCT03642262
Recruitment Status : Completed
First Posted : August 22, 2018
Results First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC ( Reckitt Benckiser Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Subjects
Intervention Drug: Mucinex®
Enrollment 30
Recruitment Details This was a single-centre study conducted in Canada.
Pre-assignment Details Total Thirty (30) subjects were enrolled in the study among them 27 subjects completed the study.
Arm/Group Title Cohort 1 (Mucinex First Then Guaifenesin) Cohort 2 (Guaifenesin Then Mucinex)
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Treatment A : Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.

Treatment B : Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.

Cohort 1

Period 1 - Treatment A or Treatment B at Sequence AB.

Period 2 - Treatment B or Treatment A at Sequence BA.

Scheduled Washout of 7 days between drug administrations.

Treatment A : Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.

Treatment B : Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.

Cohort 2

Period 1 - Treatment A or Treatment B at Sequence AB.

Period 2 - Treatment B or Treatment A at Sequence BA.

Scheduled Washout of 7 days between drug administrations.

Period Title: Period 1
Started 12 18
Completed 11 16
Not Completed 1 2
Reason Not Completed
Withdrawal by Subject             1             1
Adverse Event             0             1
Period Title: Washout: 7 Days
Started 11 16
Completed 11 16
Not Completed 0 0
Period Title: Period 2
Started 11 16
Completed 11 16
Not Completed 0 0
Arm/Group Title Overall Study
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Treatment A : Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.

Treatment B : Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.

Cohort 1

Period 1 - Treatment A or Treatment B at Sequence AB.

Period 2 - Treatment B or Treatment A at Sequence BA.

Scheduled Washout of 7 days between drug administrations.

Cohort 2

Period 1 - Treatment A or Treatment B at Sequence AB.

Period 2 - Treatment B or Treatment A at Sequence BA.

Scheduled Washout of 7 days between drug administrations.

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
40  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
15
  50.0%
Male
15
  50.0%
Age Group  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
18 to 40 years 14
41 to 64 years 16
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 30 participants
167.4  (9.1)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 30 participants
67.2  (9.9)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 30 participants
23.9  (2.2)
Race  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
Asian 5
Black or African American 6
White 19
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
Hide Description Maximum measured analyte concentration over the sampling period.
Time Frame 0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours
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Pharmacokinetic (PK) Parameter Set Population includes all subjects from the PK dataset with evaluable PK parameters for each treatment period.
Arm/Group Title Test: RB Mucinex® ER 600 mg Reference: Guaifenesin 200 mg
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Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
Overall Number of Participants Analyzed 27 27
Mean (Standard Deviation)
Unit of Measure: ng/ml
1076.37  (414.80) 1223.89  (522.04)
2.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Guaifenesin
Hide Description The area under the analyte concentration versus time curve, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear trapezoidal method.
Time Frame 0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours
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PK Dataset
Arm/Group Title Test: RB Mucinex® ER 600 mg Reference: Guaifenesin 200 mg
Hide Arm/Group Description:
Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
Overall Number of Participants Analyzed 27 27
Mean (Standard Deviation)
Unit of Measure: ng·h/ml
4288.30  (1654.57) 4641.48  (2211.99)
3.Secondary Outcome
Title Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin
Hide Description Time of the maximum measured analyte concentration over the sampling period.
Time Frame 0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours
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Hide Analysis Population Description
PK Dataset
Arm/Group Title Test: RB Mucinex® ER 600 mg Reference: Guaifenesin 200 mg
Hide Arm/Group Description:
Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
Overall Number of Participants Analyzed 27 27
Mean (Standard Deviation)
Unit of Measure: hr
0.75  (0.33) 1.45  (2.43)
4.Secondary Outcome
Title Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) of Guaifenesin
Hide Description AUCinf = AUCt + Cp/Kel, where Cp is the predicted analyte concentration at the time of the last measurable analyte concentration.
Time Frame 0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours
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Hide Analysis Population Description
PK Dataset
Arm/Group Title Test: RB Mucinex® ER 600 mg Reference: Guaifenesin 200 mg
Hide Arm/Group Description:
Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
Overall Number of Participants Analyzed 27 27
Mean (Standard Deviation)
Unit of Measure: ng·h/ml
4306.21  (1658.06) 4647.47  (2212.37)
5.Secondary Outcome
Title Terminal Elimination Rate Constant (Kel) of Guaifenesin
Hide Description Elimination rate constant calculated from the slope of the terminal portion of the plasma profile calculated by least squares regression of log (concentration) versus time
Time Frame 0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Dataset
Arm/Group Title Test: RB Mucinex® ER 600 mg Reference: Guaifenesin 200 mg
Hide Arm/Group Description:
Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
Overall Number of Participants Analyzed 27 27
Mean (Standard Deviation)
Unit of Measure: 1/h
0.4727  (0.1711) 0.7635  (0.1011)
6.Secondary Outcome
Title Terminal Elimination Half-life (T½) of Guaifenesin
Hide Description Terminal elimination half-life, calculated from the equation: T½ = In(2)/Kel.
Time Frame 0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Dataset
Arm/Group Title Test: RB Mucinex® ER 600 mg Reference: Guaifenesin 200 mg
Hide Arm/Group Description:
Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
Overall Number of Participants Analyzed 27 27
Mean (Standard Deviation)
Unit of Measure: h
1.70  (0.75) 0.93  (0.15)
7.Secondary Outcome
Title Relative Bioavailability (RF) of Guaifenesin
Hide Description RF is measured by (AUCinf ER / AUCinf IR) x (ER dose / IR dose)
Time Frame 0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours
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Outcome involved analyzing data from both intervention groups (ER and IR) in combination as per the provided formula, therefore, separate analysis for each intervention cannot be reported
Arm/Group Title All Study Participants
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Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.

Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: ng·h/ml
0.9542  (0.1770)
8.Secondary Outcome
Title Number of Adverse Events(AEs) Experienced by Participants
Hide Description Intensity determination Mild=AE does not limit usual activities; subject may experience slight discomfort Moderate=AE results in some limitation of usual activities;subject may experience significant discomfort Severe=AE results in an inability to carry out usual activities; subject may experience intolerable discomfort or pain Unassessable/Unclassifiable=Insufficient information to be able to make an assessment Conditional/Unclassified=Insufficient information to make an assessment at present (causality is conditional on additional information) Unrelated=No possibility that the AE was caused by study drug Unlikely=Slight, but remote, chance that the AE was caused by study drug, but the balance of judgment is that it was most likely not due to the study drug Possible=Reasonable suspicion that the AE was caused by the study drug Probable=Most likely that the AE was caused by study drug Certain=The AE was definitely caused by study drug Investigational Medicinal Product (IMP)
Time Frame Up to period 2 (8.3 days/200 hours)
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Safety population
Arm/Group Title Test: RB Mucinex® ER 600 mg Reference: Guaifenesin 200 mg
Hide Arm/Group Description:
Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
Overall Number of Participants Analyzed 28 29
Measure Type: Number
Unit of Measure: Events
TEAE by severity: Mild 1 9
TEAE by severity: Moderate 0 0
TEAE by severity: Severe 0 0
Relationship to IMP: Unassessable/Unclassifiable 0 3
Relationship to IMP: Conditional /Unclassified 0 0
Relationship to IMP: Unrelated 0 0
Relationship to IMP: Unlikely 0 0
Relationship to IMP: Possible 1 6
Relationship to IMP: Probable 0 0
Relationship to IMP: Certain 0 0
Time Frame Up to 8.3 days (200 hours)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment A: Mucinex® ER 600 mg Treatment B: Guaifenesin 200 mg
Hide Arm/Group Description Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition. Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
All-Cause Mortality
Treatment A: Mucinex® ER 600 mg Treatment B: Guaifenesin 200 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)      0/29 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment A: Mucinex® ER 600 mg Treatment B: Guaifenesin 200 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      0/29 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment A: Mucinex® ER 600 mg Treatment B: Guaifenesin 200 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/28 (3.57%)      4/29 (13.79%)    
Gastrointestinal disorders     
Nausea  1  0/28 (0.00%)  0 1/29 (3.45%)  1
Vomiting  1  0/28 (0.00%)  0 1/29 (3.45%)  1
General disorders     
Asthenia  1  0/28 (0.00%)  0 1/29 (3.45%)  1
Catheter site bruise  1  0/28 (0.00%)  0 1/29 (3.45%)  1
Catheter site swelling  1  0/28 (0.00%)  0 1/29 (3.45%)  1
Nervous system disorders     
Headache  1  1/28 (3.57%)  1 1/29 (3.45%)  1
Somnolence  1  0/28 (0.00%)  0 1/29 (3.45%)  1
Skin and subcutaneous tissue disorders     
Skin swelling  1  0/28 (0.00%)  0 1/29 (3.45%)  1
Vascular disorders     
Hypertension  1  0/28 (0.00%)  0 1/29 (3.45%)  1
1
Term from vocabulary, MedDRA 16.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Research Director, Clinical Research
Organization: Reckitt Benckiser Inc.
EMail: clinicalrequests@rb.com
Layout table for additonal information
Responsible Party: Reckitt Benckiser LLC ( Reckitt Benckiser Inc. )
ClinicalTrials.gov Identifier: NCT03642262     History of Changes
Other Study ID Numbers: 2013-MUC-02
First Submitted: August 20, 2018
First Posted: August 22, 2018
Results First Submitted: October 8, 2018
Results First Posted: June 17, 2019
Last Update Posted: June 17, 2019