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Bioequivalence Study Comparing Mucinex Extended-release 600 mg Tablets to Immediate-release Guaifenesin 600 mg in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03644095
Recruitment Status : Completed
First Posted : August 23, 2018
Results First Posted : June 19, 2019
Last Update Posted : June 19, 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
Interventions Drug: Mucinex® SE
Drug: Vicks Cough Syrup for Chesty Coughs
Enrollment 30
Recruitment Details This was a single-centre study.
Pre-assignment Details Total 30 subjects were enrolled in the study and all 30 subjects completed the study.
Arm/Group Title Mucinex First, Then Vicks Vicks First, Then Mucinex
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Treatment Sequences 1: Treatment A in Period 1, then Treatment B in Period 2

Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.

Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.

There was a 7 days washout period between each administration.

Treatment Sequences 2: Treatment B in Period 1, then Treatment A in Period 2

Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.

Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.

There was a 7 days washout period between each administration.

Period Title: Period 1
Started 15 15
Completed 15 15
Not Completed 0 0
Period Title: Washout (7 Days)
Started 15 15
Completed 15 15
Not Completed 0 0
Period Title: Period 2
Started 15 15
Completed 15 15
Not Completed 0 0
Arm/Group Title Overall Study
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Test (Treatment A): Subjects received a single PO (by mouth) dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.

Reference (Treatment B): Subjects received a single PO (by mouth) dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.

Period 1: Treatment A or Treatment B at Sequence AB

Period 2: Treatment B or Treatment A at Sequence BA

There was a 7 days washout period between each administration.

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
26.5  (8.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
11
  36.7%
Male
19
  63.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Caucasian
27
  90.0%
Hispanic
3
  10.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Lb
Number Analyzed 30 participants
162.2  (25.37)
Height  
Mean (Standard Deviation)
Unit of measure:  In
Number Analyzed 30 participants
68.92  (4.062)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 30 participants
23.937  (2.6486)
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
Hide Description Pharmacokinetic Parameter (Cmax) Maximum observed plasma concentration.
Time Frame 0 (pre-dose), 0.5, 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
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The Pharmacokinetic (PK) parameters were calculated from individual plasma concentration-time data (using actual blood draw times).
Arm/Group Title Test (Treatment A) Reference (Treatment B)
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Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: ng/mL
857  (469) 1390  (575)
2.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), 0.5, 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
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PK Data Set
Arm/Group Title Test (Treatment A) Reference (Treatment B)
Hide Arm/Group Description:
Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
3404.7  (1661.1) 4447.1  (1627.4)
3.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), 0.5, 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
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Hide Analysis Population Description
PK Data Set
Arm/Group Title Test (Treatment A) Reference (Treatment B)
Hide Arm/Group Description:
Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
3442.0  (1674.8) 4456.4  (1630.7)
4.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), 0.5, 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
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Hide Analysis Population Description
PK Data Set
Arm/Group Title Test (Treatment A) Reference (Treatment B)
Hide Arm/Group Description:
Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: hr
0.885  (0.537) 3.05  (2.47)
5.Primary Outcome
Title Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin
Hide Description Pharmacokinetic Parameter AUCR is the ratio of AUC(0-t) to AUC(0-inf). 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
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Hide Analysis Population Description
PK Data Set
Arm/Group Title Test (Treatment A) Reference (Treatment B)
Hide Arm/Group Description:
Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: Ratio
0.988  (0.0144) 0.998  (0.00167)
6.Primary Outcome
Title Apparent Terminal Elimination Rate Constant (Kel) of Guaifenesin
Hide Description Apparent first-order terminal elimination rate constant calculated from a semi-log 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. 3 or more non-zero plasma concentrations) in the terminal log-linear phase.
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
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Hide Analysis Population Description
PK Data Sets
Arm/Group Title Test (Treatment A) Reference (Treatment B)
Hide Arm/Group Description:
Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: 1/hr
0.373  (0.181) 0.716  (0.110)
7.Primary Outcome
Title Apparent Terminal Elimination Half-life (t1/2) of Guaifenesin
Hide Description Apparent first-order terminal elimination half-life, 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
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Hide Analysis Population Description
PK Data Set
Arm/Group Title Test (Treatment A) Reference (Treatment B)
Hide Arm/Group Description:
Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: hr
2.26  (0.948) 0.989  (0.147)
8.Secondary Outcome
Title Number of Adverse Events (AE) of Participants
Hide Description 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; Probable = Most likely that the AE was caused by study drug; Possible = Reasonable suspicion that the AE was caused by the 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.
Time Frame Upto Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Test (Treatment A) Reference (Treatment B)
Hide Arm/Group Description:
Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water.
Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: Events
TEAE by severity: Mild 7 8
TEAE by severity: Moderate 0 0
TEAE by severity: Severe 0 0
Relationship to Drug: Probable 0 0
Relationship to Drug: Possible 6 3
Relationship to Drug: Unlikely 1 5
Time Frame Up to Day 17
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test (Treatment A) Reference (Treatment B)
Hide Arm/Group Description Test (Treatment A): Subjects received a single PO dose of 1 Mucinex® 600 mg guaifenesin ER bi-layer tablet administered with 240 mL of water. Reference (Treatment B): Subjects received a single PO dose of 15 mL (200 mg) Vicks Cough Syrup for Chesty Coughs Containing Guaifenesin every 4 hours (q4h) x 3 doses each administered with 240 mL of water.
All-Cause Mortality
Test (Treatment A) Reference (Treatment B)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/30 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Test (Treatment A) Reference (Treatment B)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      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%
Test (Treatment A) Reference (Treatment B)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/30 (16.67%)      6/30 (20.00%)    
Gastrointestinal disorders     
Abdominal pain  1  1/30 (3.33%)  1 0/30 (0.00%)  0
Constipation  1  1/30 (3.33%)  1 0/30 (0.00%)  0
Dyspepsia  1  0/30 (0.00%)  0 1/30 (3.33%)  1
Injury, poisoning and procedural complications     
Skin laceration  1  0/30 (0.00%)  0 1/30 (3.33%)  1
Musculoskeletal and connective tissue disorders     
Myalgia  1  1/30 (3.33%)  1 0/30 (0.00%)  0
Nervous system disorders     
Headache  1  4/30 (13.33%)  4 2/30 (6.67%)  2
Reproductive system and breast disorders     
Dysmenorrhoea  1  0/30 (0.00%)  0 1/30 (3.33%)  2
Respiratory, thoracic and mediastinal disorders     
Dry throat  1  0/30 (0.00%)  0 1/30 (3.33%)  1
Nasal congestion  1  0/30 (0.00%)  0 1/30 (3.33%)  1
1
Term from vocabulary, MedDRA 11.1
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: NCT03644095     History of Changes
Other Study ID Numbers: 2009-GGE-02
First Submitted: August 21, 2018
First Posted: August 23, 2018
Results First Submitted: October 8, 2018
Results First Posted: June 19, 2019
Last Update Posted: June 19, 2019