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Study to Evaluate the Pharmacokinetics of Mucinex 600 mg Extended-release Bi-layer Tablet in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03644108
Recruitment Status : Completed
First Posted : August 23, 2018
Results First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC ( Reckitt Benckiser Inc. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Subjects
Intervention Drug: Mucinex® ER 600 mg
Enrollment 30
Recruitment Details This was a single-centre study.
Pre-assignment Details A total of 30 subjects were screened for the study; All 30 subjects were included single-period.
Arm/Group Title Mucinex® 600 mg ER
Hide Arm/Group Description Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Period Title: Overall Study
Started 30
Completed 30
Not Completed 0
Arm/Group Title Mucinex® 600 mg ER
Hide Arm/Group Description Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
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
26.3  (6.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
15
  50.0%
Male
15
  50.0%
Race  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Asian
1
   3.3%
Black
2
   6.7%
Caucasian
27
  90.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Lb
Number Analyzed 30 participants
160.4  (23.11)
Height  
Mean (Standard Deviation)
Unit of measure:  In
Number Analyzed 30 participants
68.41  (3.222)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 30 participants
23.976  (1.8368)
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
Hide Description Pharmacokinetic Parameters Cmax (Maximum observed drug concentration)
Time Frame 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
Data Sets Analyzed as all 30 subjects were included in the guaifenesin concentration tables and the calculation of guaifenesin Pharmacokinetic (PK) parameters.
Arm/Group Title Mucinex® 600 mg ER
Hide Arm/Group Description:
Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Overall Number of Participants Analyzed 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
876
(45.1%)
2.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin
Hide Description Area under the drug concentration-time curve calculated using linear trapezoidal summation from time zero to time t, where t is the time of the last measurable concentration (Ct).
Time Frame 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mucinex® 600 mg ER
Hide Arm/Group Description:
Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Overall Number of Participants Analyzed 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng∙hr/mL
3670
(45.4%)
3.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin
Hide Description Area under the drug concentration-time curve from time zero to infinity, AUC(0-inf) = AUC(0-t) + Ct/Kel, where Kel is the terminal elimination rate constant.
Time Frame 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mucinex® 600 mg ER
Hide Arm/Group Description:
Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Overall Number of Participants Analyzed 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng∙hr/mL
3694
(45.2%)
4.Primary Outcome
Title Time to Maximum Observed Concentration (Tmax) of Guaifenesin
Hide Description Pharmacokinetic Parameter tmax (Time of the maximum observed drug concentration).
Time Frame 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mucinex® 600 mg ER
Hide Arm/Group Description:
Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Overall Number of Participants Analyzed 30
Median (Full Range)
Unit of Measure: hr
0.752
(0.498 to 2.00)
5.Primary Outcome
Title Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin
Hide Description Ratio of AUC(0-t) to AUC(0-inf), referred to as AUCR. [AUCR = AUC(0–t) / AUC(0–inf)]
Time Frame 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mucinex® 600 mg ER
Hide Arm/Group Description:
Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: Ratio
0.9934  (0.007125)
6.Primary Outcome
Title Apparent Terminal Elimination Rate Constant (Kel) of Guaifenesin
Hide Description Apparent terminal elimination rate constant (Kel) calculated by linear regression of the terminal linear portion of the log concentration-time curve.
Time Frame 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mucinex® 600 mg ER
Hide Arm/Group Description:
Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: 1/hr
0.455  (0.200)
7.Primary Outcome
Title Apparent Terminal Elimination Half-life (t1/2) of Guaifenesin
Hide Description Apparent terminal elimination half-life (t1/2) calculated as ln(2)/Kel.
Time Frame 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mucinex® 600 mg ER
Hide Arm/Group Description:
Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: hr
1.91  (1.11)
8.Secondary Outcome
Title Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Hide Description

Intensity was determined by the Investigator. For symptomatic AEs the following definitions were applied.

Mild = AE did not limit usual activities; subject may have experienced slight discomfort.

Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort.

Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain.

Relationship to Investigational Medicinal Products (IMP)

Unlikely = Slight, but remote, chance that AE was caused by IMP. Possible = Reasonable suspicion that the AE was caused by IMP. Probable = Most likely that AE was caused by IMP.

Time Frame Up to Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mucinex® 600 mg ER
Hide Arm/Group Description:
Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
TEAE by severity: Mild 5
TEAE by severity: Moderate 0
TEAE by severity: Severe 0
Relationship to IMP - Unlikely 5
Relationship to IMP – Possible 0
Relationship to IMP – Probable 0
Time Frame Up to Day 2
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mucinex® 600 mg ER
Hide Arm/Group Description Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
All-Cause Mortality
Mucinex® 600 mg ER
Affected / at Risk (%)
Total   5/30 (16.67%)    
Show Serious Adverse Events Hide Serious Adverse Events
Mucinex® 600 mg ER
Affected / at Risk (%) # Events
Total   0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mucinex® 600 mg ER
Affected / at Risk (%) # Events
Total   5/30 (16.67%)    
Nervous system disorders   
Headache  1  4/30 (13.33%)  4
Respiratory, thoracic and mediastinal disorders   
Nasal congestion  1  1/30 (3.33%)  1
1
Term from vocabulary, 12.0
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
Name/Title: Clinical Research Director, Clinical Research
Organization: Reckitt Benckiser, Inc
Responsible Party: Reckitt Benckiser LLC ( Reckitt Benckiser Inc. )
ClinicalTrials.gov Identifier: NCT03644108     History of Changes
Other Study ID Numbers: 2009-GGE-04
First Submitted: August 21, 2018
First Posted: August 23, 2018
Results First Submitted: September 18, 2018
Results First Posted: February 28, 2019
Last Update Posted: February 28, 2019