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Mucinex® ER 600 mg Bi-Layer Tablet Fed and Fasted

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ClinicalTrials.gov Identifier: NCT03649750
Recruitment Status : Completed
First Posted : August 28, 2018
Results First Posted : February 22, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC

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 36
Recruitment Details This was a single-centre study.
Pre-assignment Details Total Thirty-six (36) subjects were enrolled in the study among them 36 subjects completed the study.
Arm/Group Title Cohort 1(Mucinex Fed or Mucinex Fast in Period 1 and Period 2) Cohort 2(Mucinex Fast or Mucinex Fed in Period 1 and Period 2)
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Treatment A (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.

Treatment B (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.

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 doses.

Treatment A (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.

Treatment B (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.

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 doses.

Period Title: Period 1
Started 12 24
Completed 12 24
Not Completed 0 0
Period Title: Washout: 7 Days
Started 12 24
Completed 12 24
Not Completed 0 0
Period Title: Period 2
Started 12 24
Completed 12 24
Not Completed 0 0
Arm/Group Title Pharmacokinetic (PK) Dataset
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Treatment A (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.

Treatment B (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.

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 doses.

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 doses.

Overall Number of Baseline Participants 36
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Pharmacokinetic (PK) Dataset Subjects from whom the observation/estimation of Cmax and AUC measures/parameters were possible for two periods were included in the PK dataset.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants
37  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
17
  47.2%
Male
19
  52.8%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 36 participants
170.8  (10.1)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 36 participants
72.3  (10.4)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 36 participants
24.7  (2.1)
Age  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants
18 - 40 years 21
41 - 64 years 15
Race  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants
Asian 6
Black or African American 8
White 22
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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)
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Pharmacokinetic (PK) Dataset are the Subjects from whom the observation/estimation of Cmax and AUC measures/parameters will be possible for two periods will be included in the PK dataset.

The PK dataset will be defined prior to the assay of samples.

Arm/Group Title Treatment A: Mucinex® 600 mg (Fast) Treatment B: Mucinex® 600 mg (Fed)
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Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.
Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: ng/ml
1066.11  (429.91) 1117.31  (424.82)
2.Primary Outcome
Title Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Plasma 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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)
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Pharmacokinetic Dataset
Arm/Group Title Treatment A: Mucinex® 600 mg (Fast) Treatment B: Mucinex® 600 mg (Fed)
Hide Arm/Group Description:
Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.
Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: ng·h/ml
4052.10  (1495.48) 4084.90  (1380.20)
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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)
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Pharmacokinetic Dataset
Arm/Group Title Treatment A: Mucinex® 600 mg (Fast) Treatment B: Mucinex® 600 mg (Fed)
Hide Arm/Group Description:
Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.
Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: h
0.68  (0.32) 3.33  (1.36)
4.Secondary Outcome
Title Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) of Guaifenesin
Hide Description

The area under the analyte concentration versus time curve from time zero to infinity.

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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)
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Pharmacokinetic Dataset
Arm/Group Title Treatment A: Mucinex® 600 mg (Fast) Treatment B: Mucinex® 600 mg (Fed)
Hide Arm/Group Description:
Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.
Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: ng·h/ml
4104.47  (1555.87) 4092.53  (1382.77)
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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)
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Pharmacokinetic Dataset
Arm/Group Title Treatment A: Mucinex® 600 mg (Fast) Treatment B: Mucinex® 600 mg (Fed)
Hide Arm/Group Description:
Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.
Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: 1/h
0.3862  (0.1717) 0.6788  (0.1343)
6.Secondary Outcome
Title Terminal Elimination Half-life (T½) of Guaifenesin
Hide Description Terminal elimination half-life, calculated from the equation: thalf = 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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)
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Pharmacokinetic Dataset
Arm/Group Title Treatment A: Mucinex® 600 mg (Fast) Treatment B: Mucinex® 600 mg (Fed)
Hide Arm/Group Description:
Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.
Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.
Overall Number of Participants Analyzed 36 36
Mean (Standard Deviation)
Unit of Measure: h
2.46  (2.62) 1.07  (0.29)
7.Secondary Outcome
Title Relative Bioavailability (RF) of Guaifenesin
Hide Description

Relative bioavailability for each formulation will be defined as:

(AUC0-inf Fasting ÷ AUC0-inf Fed) x (Fed dose ÷ Fasting 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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)
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Outcome involved analyzing data from both intervention groups (Fed and Fasting) 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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Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting and fed.
Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: Percent bioavailability
1.0081  (0.1655)
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
Time Frame Up to period 2 (8.3 days/200 hours)
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Pharmacokinetic Dataset

Investigational Medicinal Product(IMP)

Arm/Group Title Treatment A: Mucinex® 600 mg (Fast) Treatment B: Mucinex® 600 mg (Fed)
Hide Arm/Group Description:
Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.
Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.
Overall Number of Participants Analyzed 36 36
Measure Type: Number
Unit of Measure: Events
TEAE by severity: Mild 11 14
TEAE by severity: Moderate 0 0
TEAE by severity: Severe 0 0
Relationship to IMP: Unassessable/Unclassifiable 3 5
Relationship to IMP: Conditional /Unclassified 0 0
Relationship to IMP: Unrelated 2 0
Relationship to IMP: Unlikely 0 0
Relationship to IMP: Possible 6 9
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® 600 mg (Fast) Treatment B: Mucinex® 600 mg (Fed)
Hide Arm/Group Description Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting. Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.
All-Cause Mortality
Treatment A: Mucinex® 600 mg (Fast) Treatment B: Mucinex® 600 mg (Fed)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)      0/36 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment A: Mucinex® 600 mg (Fast) Treatment B: Mucinex® 600 mg (Fed)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/36 (0.00%)      0/36 (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® 600 mg (Fast) Treatment B: Mucinex® 600 mg (Fed)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/36 (22.22%)      10/36 (27.78%)    
Cardiac disorders     
Tachycardia  1  1/36 (2.78%)  1 0/36 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain lower  1  1/36 (2.78%)  1 0/36 (0.00%)  0
General disorders     
Vessel puncture site bruise  1  0/36 (0.00%)  0 1/36 (2.78%)  1
Vessel puncture site pain  1  0/36 (0.00%)  0 1/36 (2.78%)  1
Vessel puncture site swelling  1  0/36 (0.00%)  0 1/36 (2.78%)  1
Nervous system disorders     
Headache  1  1/36 (2.78%)  1 2/36 (5.56%)  2
Somnolence  1  5/36 (13.89%)  5 6/36 (16.67%)  6
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  1/36 (2.78%)  1 0/36 (0.00%)  0
Vascular disorders     
Hypertension  1  2/36 (5.56%)  2 1/36 (2.78%)  1
1
Term from vocabulary, MedDRA 16.0
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
ClinicalTrials.gov Identifier: NCT03649750     History of Changes
Other Study ID Numbers: 2013-MUC-01
First Submitted: August 20, 2018
First Posted: August 28, 2018
Results First Submitted: October 8, 2018
Results First Posted: February 22, 2019
Last Update Posted: March 27, 2019