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Study to Evaluate the Pharmacokinetics of Guaifenesin in Adults and Adolescents

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ClinicalTrials.gov Identifier: NCT03633448
Recruitment Status : Completed
First Posted : August 16, 2018
Results First Posted : June 17, 2019
Last Update Posted : June 17, 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: Children's Mucinex® Grape Flavor
Enrollment 24
Recruitment Details This was a single-centre study.
Pre-assignment Details Total 24 subjects were enrolled in the study and all 24 completed the study.
Arm/Group Title 200mg Dose of Guaifenesin, Then 400mg Dose of Guaifenesin 400mg Dose of Guaifenesin, Then 200mg Dose of Guaifenesin
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Treatment Sequences 1 [6 adolescents/6 adults]: Treatment A in Period 1, then Treatment B in Period 2

Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.

Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.

There was a 7 days washout period between each administration.

Treatment Sequences 2 [6 adolescents/6 adults]: Treatment B in Period 1, then Treatment A in Period 2.

Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.

Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.

There was a 7 days washout period between each administration.

Period Title: Period 1 (1 Day)
Started 12 12
Completed 12 12
Not Completed 0 0
Period Title: Washout (7 Days)
Started 12 12
Completed 12 12
Not Completed 0 0
Period Title: Period 2 (1 Day)
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title Adolescent Adult Total
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Treatment A: Single 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.

Treatment B: Single 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.

There was a 7 days washout period between each administration.

Treatment A: Single 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.

Treatment B: Single 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.

There was a 7 days washout period between each administration.

Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
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[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
14.3  (1.71) 32.2  (12.42) 23.2  (12.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
7
  58.3%
8
  66.7%
15
  62.5%
Male
5
  41.7%
4
  33.3%
9
  37.5%
Race  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Asian
1
   8.3%
2
  16.7%
3
  12.5%
Black or African American
10
  83.3%
8
  66.7%
18
  75.0%
White
1
   8.3%
2
  16.7%
3
  12.5%
Ethnicity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Hispanic or Latino
1
   8.3%
0
   0.0%
1
   4.2%
Non-Hispanic and Non-Latino
11
  91.7%
12
 100.0%
23
  95.8%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 12 participants 12 participants 24 participants
163.9  (7.69) 166.83  (10.954) 165.35  (9.379)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 12 participants 12 participants 24 participants
56.03  (7.198) 66.88  (11.611) 61.45  (10.955)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 12 participants 12 participants 24 participants
20.78  (1.482) 23.98  (3.168) 22.38  (2.917)
1.Primary Outcome
Title Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin
Hide Description Area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration, as calculated by the linear trapezoidal method.
Time Frame 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
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Pharmacokinetic (PK) Data Sets included only those subjects who swallowed the whole dose (did not spit it out), did not vomit within one hour of dosing, and who had a sufficient number of plasma concentrations to estimate the primary PK parameters for at least one dose level.
Arm/Group Title Treatment A (Adolescents) Treatment A (Adults) Treatment B (Adolescents) Treatment B (Adults)
Hide Arm/Group Description:
Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
1990  (929) 1700  (742) 4390  (1590) 3910  (1500)
2.Primary Outcome
Title Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin
Hide Description Area under the plasma concentration versus time curve from time 0 to infinity, calculated as AUC 0-t + C last/kel, where C last is the last measurable concentration and kel is the apparent first-order terminal elimination rate constant.
Time Frame 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
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PK Data Sets
Arm/Group Title Treatment A (Adolescents) Treatment A (Adults) Treatment B (Adolescents) Treatment B (Adults)
Hide Arm/Group Description:
Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
2090  (916) 1710  (744) 4400  (1600) 3930  (1500)
3.Primary Outcome
Title Percent of AUC 0-inf Extrapolated (AUC%Extrapolated)
Hide Description Percent of AUC 0-inf extrapolated, calculated as (1 – AUC 0-t / AUC 0-inf) x 100.
Time Frame 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
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Hide Analysis Population Description
PK Data Sets
Arm/Group Title Treatment A (Adolescents) Treatment A (Adults) Treatment B (Adolescents) Treatment B (Adults)
Hide Arm/Group Description:
Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: Percentage
0.469  (0.426) 0.736  (0.775) 0.476  (0.431) 0.386  (0.134)
4.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
Hide Description Pharmacokinetic Parameter (Cmax) Maximum observed plasma concentration.
Time Frame 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
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Hide Analysis Population Description
PK Data Sets
Arm/Group Title Treatment A (Adolescents) Treatment A (Adults) Treatment B (Adolescents) Treatment B (Adults)
Hide Arm/Group Description:
Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
1360  (968) 887  (419) 2690  (1220) 1950  (739)
5.Primary Outcome
Title Time to Maximum Observed Concentration (Tmax) of Guaifenesin
Hide Description Pharmacokinetic Parameter (Tmax) Time of the maximum observed plasma concentration.
Time Frame 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
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Hide Analysis Population Description
PK Data Sets
Arm/Group Title Treatment A (Adolescents) Treatment A (Adults) Treatment B (Adolescents) Treatment B (Adults)
Hide Arm/Group Description:
Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: hr
0.458  (0.209) 0.711  (0.403) 0.524  (0.325) 0.646  (0.345)
6.Primary Outcome
Title Apparent First-order Terminal Elimination Half-life (t½)
Hide Description Apparent first-order terminal elimination half-life, calculated as ln(2)/kel.
Time Frame 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
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Hide Analysis Population Description
PK Data Sets
Arm/Group Title Treatment A (Adolescents) Treatment A (Adults) Treatment B (Adolescents) Treatment B (Adults)
Hide Arm/Group Description:
Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: hr
1.05  (0.173) 1.10  (0.228) 0.963  (0.129) 0.963  (0.0899)
7.Primary Outcome
Title Apparent First-order Terminal Elimination Rate Constant (Kel)
Hide Description Apparent first-order terminal elimination rate constant calculated from a semilog plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares (LS) regression analysis using the maximum number of points (e.g., three or more non-zero plasma concentrations) in the terminal log-linear phase.
Time Frame 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
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Hide Analysis Population Description
PK Data Sets
Arm/Group Title Treatment A (Adolescents) Treatment A (Adults) Treatment B (Adolescents) Treatment B (Adults)
Hide Arm/Group Description:
Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: 1/hr
0.678  (0.100) 0.655  (0.122) 0.731  (0.0928) 0.726  (0.0757)
8.Secondary Outcome
Title Number of Adverse Events (AEs) of 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; 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.

Time Frame Upto Day 1
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PK Data Sets
Arm/Group Title Treatment A (Adolescents) Treatment A (Adults) Treatment B (Adolescents) Treatment B (Adults)
Hide Arm/Group Description:
Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
Overall Number of Participants Analyzed 12 12 12 12
Measure Type: Number
Unit of Measure: Events
TEAE by severity: Mild 0 0 0 1
TEAE by severity: Moderate 0 0 0 1
TEAE by severity: Severe 0 0 0 0
Relationship to Drug: Definite 0 0 0 0
Relationship to Drug: Probable 0 0 0 0
Relationship to Drug: Possible 0 0 0 0
Relationship to Drug: Unlikely 0 0 0 0
Relationship to Drug: None 0 0 0 2
Time Frame Up to Day 14
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment A (Adolescents) Treatment A (Adults) Treatment B (Adolescents) Treatment B (Adults)
Hide Arm/Group Description Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast. Treatment A: Single 200 mg (10 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast. Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast. Treatment B: Single 400 mg (20 mL) Children’s Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate Release by oral syringe under overnight fast.
All-Cause Mortality
Treatment A (Adolescents) Treatment A (Adults) Treatment B (Adolescents) Treatment B (Adults)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/12 (0.00%)      0/12 (0.00%)      1/12 (8.33%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment A (Adolescents) Treatment A (Adults) Treatment B (Adolescents) Treatment B (Adults)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)      0/12 (0.00%)      0/12 (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 (Adolescents) Treatment A (Adults) Treatment B (Adolescents) Treatment B (Adults)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)      0/12 (0.00%)      1/12 (8.33%)    
Gastrointestinal disorders         
Dyspepsia  1  0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Infections and infestations         
Gastroenteritis  1  0/12 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
1
Term from vocabulary, MedDRA 14.0
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
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
ClinicalTrials.gov Identifier: NCT03633448     History of Changes
Other Study ID Numbers: 2011-GGE-06
First Submitted: August 14, 2018
First Posted: August 16, 2018
Results First Submitted: September 24, 2018
Results First Posted: June 17, 2019
Last Update Posted: June 17, 2019