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Study to Evaluate the Pharmacokinetics of Mucinex® 1200 mg Extended-Release Tablet

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ClinicalTrials.gov Identifier: NCT03633487
Recruitment Status : Completed
First Posted : August 16, 2018
Results First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Subjects
Intervention Drug: Mucinex®
Enrollment 24
Recruitment Details This was a single-centre study.
Pre-assignment Details A total of 24 subjects entered the study; All 24 subjects were included single-period.
Arm/Group Title Mucinex® 1200 mg
Hide Arm/Group Description Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Period Title: Overall Study
Started 24
Completed 24
Not Completed 0
Arm/Group Title Mucinex® 1200 mg
Hide Arm/Group Description Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
30.4  (10.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
7
  29.2%
Male
17
  70.8%
Race  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants
Asian 1
Black or African American 1
White 22
Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants
Hispanic or Latino 2
Not Hispanic or Latino 22
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 24 participants
75.42  (12.711)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 24 participants
175.8  (9.65)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 24 participants
24.220  (2.4480)
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description Pharmacokinetic Parameters (Cmax) Maximum observed plasma concentration.
Time Frame 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population includes subjects with at least one PK sample. Available data from any subjects who vomited within 12 hours after dosing were to be included in the PK data sets.
Arm/Group Title Mucinex® 1200 mg
Hide Arm/Group Description:
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: ng/mL
1634  (769.95)
2.Primary Outcome
Title Time of the Maximum Observed Plasma Concentration (Tmax)
Hide Description Pharmacokinetic Parameter (Tmax) Time of the maximum observed plasma concentration
Time Frame 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mucinex® 1200 mg
Hide Arm/Group Description:
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: hr
0.9753  (0.61407)
3.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t)
Hide Description Pharmacokinetic Parameter (AUC0-t) is Area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration
Time Frame 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mucinex® 1200 mg
Hide Arm/Group Description:
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
6515.5  (2765.33)
4.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf)
Hide Description Pharmacokinetic Parameter (AUC0-inf) Area under the plasma concentration versus time curve from time 0 to infinity.
Time Frame 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mucinex® 1200 mg
Hide Arm/Group Description:
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
6733.5  (2831.57)
5.Primary Outcome
Title Percentage of AUC0-inf Extrapolated Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin
Hide Description Pharmacokinetic Parameter (AUC%extrap) Percent of AUC0-inf extrapolated AUCR = 100 - (AUC0-t/ AUC0-inf) x 100
Time Frame 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mucinex® 1200 mg
Hide Arm/Group Description:
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: Percentage of AUC0-inf extrapolated AUCR
1.950  (2.7458)
6.Primary Outcome
Title Apparent First-order Terminal Elimination Rate Constant (Kel)
Hide Description Pharmacokinetic Parameter (Kel) Apparent first-order terminal elimination rate constant
Time Frame 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mucinex® 1200 mg
Hide Arm/Group Description:
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: 1/hr
0.2644  (0.16374)
7.Primary Outcome
Title Terminal Elimination Half Life (t1/2)
Hide Description Pharmacokinetic Parameter (t1/2) is Apparent terminal elimination half-life.
Time Frame 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mucinex® 1200 mg
Hide Arm/Group Description:
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: hr
3.374  (1.6383)
8.Primary Outcome
Title Time at Which the Percentage of Subjects Achieved a Target Concentration of at Least 65 ng/mL (T65)
Hide Description Pharmacokinetic Parameter (T65) is te time when guaifenesin plasma concentration achieved a target concentration of at least 65 ng/mL.
Time Frame 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mucinex® 1200 mg
Hide Arm/Group Description:
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: hr
0.1999  (0.10427)
9.Secondary Outcome
Title Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
Hide Description

Intensity was determined by the Investigator. For symptomatic adverse events (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® 1200 mg
Hide Arm/Group Description:
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
TEAE by severity: Mild 3
TEAE by severity: Moderate 0
TEAE by severity: Severe 0
Relationship to IMP - Definite 0
Relationship to IMP - Probable 0
Relationship to IMP - Possible 1
Relationship to IMP - Unlikely 0
Relationship to IMP - None 2
Time Frame Up to Day 2
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mucinex® 1200 mg
Hide Arm/Group Description Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
All-Cause Mortality
Mucinex® 1200 mg
Affected / at Risk (%)
Total   0/24 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Mucinex® 1200 mg
Affected / at Risk (%) # Events
Total   0/24 (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® 1200 mg
Affected / at Risk (%) # Events
Total   3/24 (12.50%)    
General disorders   
Catheter site swelling  1  1/24 (4.17%)  1
Oedema peripheral  1  1/24 (4.17%)  1
Nervous system disorders   
Headache  1  1/24 (4.17%)  1
Presyncope  1  1/24 (4.17%)  1
1
Term from vocabulary, MedDRA 14.1
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
Name/Title: Clinical Research Director, Clinical Research
Organization: Reckitt Benckiser, Inc
Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT03633487     History of Changes
Other Study ID Numbers: 2011-MUC-05
First Submitted: August 14, 2018
First Posted: August 16, 2018
Results First Submitted: September 18, 2018
Results First Posted: February 28, 2019
Last Update Posted: February 28, 2019