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Study to Characterize the Pharmacokinetics of 3 Marketed Products Containing 200 mg Guaifenesin in Healthy Volunteers.

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ClinicalTrials.gov Identifier: NCT03643575
Recruitment Status : Completed
First Posted : August 23, 2018
Results First Posted : February 22, 2019
Last Update Posted : March 27, 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: Vicks Cough Syrup for Chesty Coughs
Drug: Robitussin Extra Strength Chest Congestion
Drug: Organ-I- NR tablet
Enrollment 30
Recruitment Details This was a single-centre study.
Pre-assignment Details A total of 30 subjects entered the study, among them 27 subjects completed the study.
Arm/Group Title Treatment Sequence 1 Treatment Sequence 2 Treatment Sequence 3 Treatment Sequence 4 Treatment Sequence 5 Treatment Sequence 6
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Period 1: Treatment A

Vicks Cough Syrup 15ml containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

Period 2: Treatment B

Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

Period 3: Treatment C

Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

There was a 7 days washout period between each administration

Period 1: Treatment B

Robitussin Extra Strength 5ml syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

Period 2: Treatment C

Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

Period 3: Treatment A

Vicks Cough Syrup 15ml containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

There was a 7 days washout period between each administration

Period 1: Treatment C

Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

Period 2: Treatment A

Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

Period 3: Treatment B

Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

There was a 7 days washout period between each administration

Period 1: Treatment A

Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

Period 2: Treatment C

Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

Period 3: Treatment B

Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

There was a 7 days washout period between each administration

Period 1: Treatment B

Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

Period 2: Treatment A

Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

Period 3: Treatment C

Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

There was a 7 days washout period between each administration

Period 1: Treatment C

Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

Period 2: Treatment B

Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

Period 3: Treatment A

Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

There was a 7 days washout period between each administration

Period Title: Period 1
Started 5 5 5 5 5 5
Completed 5 5 5 5 5 5
Not Completed 0 0 0 0 0 0
Period Title: Washout: 7 Days
Started 5 5 5 5 5 5
Completed 4 5 5 4 5 5
Not Completed 1 0 0 1 0 0
Reason Not Completed
Withdrew consent due to illness             0             0             0             1             0             0
Adverse Event             1             0             0             0             0             0
Period Title: Period 2
Started 4 5 5 4 5 5
Completed 4 5 5 4 5 5
Not Completed 0 0 0 0 0 0
Period Title: Washout: 7 Days
Started 4 5 5 4 5 5
Completed 4 4 5 4 5 5
Not Completed 0 1 0 0 0 0
Reason Not Completed
Non compliance check in             0             1             0             0             0             0
Period Title: Period 3
Started 4 4 5 4 5 5
Completed 4 4 5 4 5 5
Not Completed 0 0 0 0 0 0
Arm/Group Title Overall Study
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Treatment A:

Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

Treatment B:

Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

Treatment C:

Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast

There was a 7 days washout period between each administration

Participants randomized to receive either Treatment A or Treatment B or Treatment C in 3 Periods (Period 1, 2, 3) of 6 sequence (ABC, BCA, CAB, ACB, BAC, CBA)

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
26.0  (9.54)
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: Number
Unit of measure:  Participants
Number Analyzed 30 participants
Asian 1
Black 1
Caucasian 25
European/Middle Eastern 1
Hispanic 2
Weight  
Mean (Standard Deviation)
Unit of measure:  Lb
Number Analyzed 30 participants
157.60  (22.359)
Height  
Mean (Standard Deviation)
Unit of measure:  In
Number Analyzed 30 participants
69.65  (3.246)
Frame Size  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
Small 4
Medium 23
Large 3
Elbow Breadth  
Mean (Standard Deviation)
Unit of measure:  In
Number Analyzed 30 participants
2.661  (0.2140)
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
Hide Description Pharmacokinetic Parameter Cmax is 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 and 16 hours
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Pharmacokinetic (PK) analyses were performed on the available data of the subjects that completed at least 1 period.
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description:
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Overall Number of Participants Analyzed 26 28 28
Mean (Standard Deviation)
Unit of Measure: ng/mL
1730  (723) 1230  (456) 1110  (433)
2.Primary Outcome
Title Maximum Measured Plasma Concentration at Steady State (Cmax,ss) of Guaifenesin Following the Third Dose
Hide Description Pharmacokinetic Parameter Cmax,ss is the Maximum observed plasma concentration following the third dose.
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 and 16 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK analyses
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description:
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Overall Number of Participants Analyzed 26 28 28
Mean (Standard Deviation)
Unit of Measure: ng/mL
876  (548) 765  (309) 796  (317)
3.Primary Outcome
Title Observed Plasma Concentration at the End of Dosing Interval at Steady State (Cmin,ss) of Guaifenesin Following the Third Dose
Hide Description Observed plasma concentration at the end of the dosing interval following the third dose (that is, 4 hours following the third dose).
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 and 16 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK analyses
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description:
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Overall Number of Participants Analyzed 26 28 28
Mean (Standard Deviation)
Unit of Measure: ng/mL
60.3  (33.4) 55.1  (28.0) 73.6  (59.9)
4.Primary Outcome
Title Average Plasma Concentration (Cav) of Guaifenesin Following the Third Dose
Hide Description

Average plasma concentration (Cav) following the third dose, calculated as AUC(8-12) divided by the dosing interval, 4.

Cav is calculated as AUC(8-12) / dosing interval, 4

Time Frame 8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK analyses
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description:
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Overall Number of Participants Analyzed 26 28 28
Mean (Standard Deviation)
Unit of Measure: ng/mL
357  (168) 313  (128) 300  (128)
5.Primary Outcome
Title Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin
Hide Description Pharmacokinetic Parameter Tmax is the 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 and 16 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK analyses
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description:
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Overall Number of Participants Analyzed 26 28 28
Mean (Standard Deviation)
Unit of Measure: hr
2.66  (2.32) 2.94  (2.00) 3.91  (2.29)
6.Primary Outcome
Title Time to Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of Guaifenesin Following the Third Dose
Hide Description Pharmacokinetic Parameter Tmax, ss is the time of the maximum observed plasma concentration following the third dose.
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 and 16 hours
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Hide Analysis Population Description
PK analyses
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description:
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Overall Number of Participants Analyzed 26 28 28
Mean (Standard Deviation)
Unit of Measure: hr
8.70  (0.333) 8.67  (0.244) 9.02  (0.374)
7.Primary Outcome
Title Apparent First-order Terminal Elimination Half-life (T1/2) of Guaifenesin
Hide Description T1/2 is the 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 and 16 hours
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PK analyses
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description:
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Overall Number of Participants Analyzed 26 27 28
Mean (Standard Deviation)
Unit of Measure: hr
0.961  (0.0973) 1.04  (0.138) 0.941  (0.130)
8.Primary Outcome
Title Apparent First-order Terminal Elimination Rate Constant (Kel) of Guaifenesin
Hide Description Kel is the 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 and 16 hours
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Hide Analysis Population Description
PK analyses
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description:
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Overall Number of Participants Analyzed 26 27 28
Mean (Standard Deviation)
Unit of Measure: 1/hr
0.729  (0.0780) 0.677  (0.0898) 0.750  (0.0987)
9.Primary Outcome
Title Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration [AUC(0-t)] of Guaifenesin
Hide Description AUC(0-t) is the 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 and 16 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK analyses
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description:
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Overall Number of Participants Analyzed 26 28 28
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
5588.99  (2329.08) 4369.98  (1708.25) 4223.74  (1798.98)
10.Primary Outcome
Title Area Under Plasma Concentration Versus Time Curve From Time 0 to Infinity [AUC(0-inf)] of Guaifenesin
Hide Description AUC(0-inf) is the area under the plasma concentration versus time curve from time 0 to infinity, calculated as AUC(0-t) + Ct/Kel, where Ct was 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 and 16 hours
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Hide Analysis Population Description
PK analyses
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description:
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Overall Number of Participants Analyzed 26 27 28
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
5596.33  (2330.20) 4427.06  (1721.91) 4232.61  (1801.69)
11.Primary Outcome
Title Area Under Plasma Concentration Versus Time Curve From 0 to 4 Hours [AUC(0-4)] of Guaifenesin
Hide Description AUC(0-4) is the area under the plasma concentration versus time curve from time 0 to 4 hours post dose (relative to first dose), as calculated by the linear trapezoidal method.
Time Frame 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3 and 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK analyses
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description:
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Overall Number of Participants Analyzed 26 28 28
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
2013.16  (785.006) 1490.15  (579.667) 1414.18  (617.126)
12.Primary Outcome
Title Area Under Plasma Concentration Versus Time Curve From Time 8 to 12 Hours [AUC(8-12)] of Guaifenesin
Hide Description AUC(8-12) is the area under the plasma concentration versus time curve from time 8 to 12 hours postdose (relative to first dose), as calculated by the linear trapezoidal method.
Time Frame 8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hours
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Hide Analysis Population Description
PK analyses
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description:
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Overall Number of Participants Analyzed 26 28 28
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
1427.70  (672.821) 1253.09  (511.519) 1198.55  (511.210)
13.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 and 16 hours
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Hide Analysis Population Description
PK analyses
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description:
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Overall Number of Participants Analyzed 26 27 28
Mean (Standard Deviation)
Unit of Measure: Ratio
0.9986  (0.000592) 0.9982  (0.001138) 0.9978  (0.001724)
14.Primary Outcome
Title Accumulation Index (AI) of Guaifenesin
Hide Description AI is the accumulation index, calculated as AUC(8-12) / AUC(0-4).
Time Frame 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4 hours and 8, 8.5, 8.75, 9, 9.5, 10, 11, 12 hours
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Hide Analysis Population Description
PK analyses
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description:
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Overall Number of Participants Analyzed 26 28 28
Mean (Standard Deviation)
Unit of Measure: Ratio
0.7056  (0.1299) 0.8420  (0.1180) 0.8592  (0.1304)
15.Primary Outcome
Title Degree of Fluctuation (DF) of Guaifenesin
Hide Description DF is the Degree of Fluctuation Index, calculated as (Cmax,ss – Cmin,ss) / Cav.
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 and 16 hours
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Hide Analysis Population Description
PK analyses
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description:
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Overall Number of Participants Analyzed 26 28 28
Mean (Standard Deviation)
Unit of Measure: Percent fluctuation in concentration
2.220  (0.5508) 2.312  (0.5221) 2.463  (0.6758)
16.Primary Outcome
Title Peak Plasma Concentrations at Steady State (Swing) of Guaifenesin
Hide Description Pharmacokinetic Parameter Swing is Calculated as (Cmax,ss – Cmin,ss) / Cmin,ss.
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 and 16 hours
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Hide Analysis Population Description
PK analyses
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description:
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Overall Number of Participants Analyzed 26 28 28
Mean (Standard Deviation)
Unit of Measure: Percentage
16.19  (10.03) 15.62  (8.908) 0.750  (0.0987)
17.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
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 (Period 3)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analyses
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description:
Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
Overall Number of Participants Analyzed 29 28 28
Measure Type: Number
Unit of Measure: participants
TEAE by severity: Mild 5 1 4
TEAE by severity: Moderate 2 0 1
TEAE by severity: Severe 0 0 0
Relationship to IMP - Unlikely 5 1 2
Relationship to IMP - Possible 1 0 2
Relationship to IMP - Probable 0 0 0
Time Frame Up to day 2 (Period 3)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment A Treatment B Treatment C
Hide Arm/Group Description Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast
All-Cause Mortality
Treatment A Treatment B Treatment C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)      0/28 (0.00%)      0/28 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment A Treatment B Treatment C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/29 (0.00%)      0/28 (0.00%)      0/28 (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 Treatment B Treatment C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/29 (17.24%)      1/28 (3.57%)      4/28 (14.29%)    
Gastrointestinal disorders       
Abdominal pain upper  1  1/29 (3.45%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Diarrhoea  1  1/29 (3.45%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Vomiting  1  1/29 (3.45%)  1 0/28 (0.00%)  0 1/28 (3.57%)  1
General disorders       
Feeling hot  1  1/29 (3.45%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Vessel puncture site haematoma  1  1/29 (3.45%)  2 0/28 (0.00%)  0 0/28 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Myalgia  1  0/29 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
Nervous system disorders       
Dizziness  1  1/29 (3.45%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Headache  1  2/29 (6.90%)  2 1/28 (3.57%)  1 2/28 (7.14%)  3
Reproductive system and breast disorders       
Dysmenorrhoea  1  1/29 (3.45%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Vulvovaginal pruritus  1  1/29 (3.45%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain  1  0/29 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1
1
Term from vocabulary, MedDRA 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
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: NCT03643575     History of Changes
Other Study ID Numbers: 2009-GGE-05
First Submitted: August 21, 2018
First Posted: August 23, 2018
Results First Submitted: October 8, 2018
Results First Posted: February 22, 2019
Last Update Posted: March 27, 2019