Trial Outcomes & Findings for Mucinex® ER 600 mg Bi-layer Tablet Versus Guaifenesin Immediate Release (IR) 200 mg q4h (NCT NCT03642262)
NCT ID: NCT03642262
Last Updated: 2019-06-17
Results Overview
Maximum measured analyte concentration over the sampling period.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours
Results posted on
2019-06-17
Participant Flow
This was a single-centre study conducted in Canada.
Total Thirty (30) subjects were enrolled in the study among them 27 subjects completed the study.
Participant milestones
| Measure |
Cohort 1 (Mucinex First Then Guaifenesin)
Treatment A : Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
Treatment B : Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
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 administrations.
|
Cohort 2 (Guaifenesin Then Mucinex)
Treatment A : Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
Treatment B : Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
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 administrations.
|
|---|---|---|
|
Period 1
STARTED
|
12
|
18
|
|
Period 1
COMPLETED
|
11
|
16
|
|
Period 1
NOT COMPLETED
|
1
|
2
|
|
Washout: 7 Days
STARTED
|
11
|
16
|
|
Washout: 7 Days
COMPLETED
|
11
|
16
|
|
Washout: 7 Days
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
11
|
16
|
|
Period 2
COMPLETED
|
11
|
16
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 (Mucinex First Then Guaifenesin)
Treatment A : Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
Treatment B : Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
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 administrations.
|
Cohort 2 (Guaifenesin Then Mucinex)
Treatment A : Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
Treatment B : Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
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 administrations.
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
1
|
1
|
|
Period 1
Adverse Event
|
0
|
1
|
Baseline Characteristics
Mucinex® ER 600 mg Bi-layer Tablet Versus Guaifenesin Immediate Release (IR) 200 mg q4h
Baseline characteristics by cohort
| Measure |
Overall Study
n=30 Participants
Treatment A : Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
Treatment B : Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
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 administrations.
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 administrations.
|
|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Age Group
18 to 40 years
|
14 Participants
n=5 Participants
|
|
Age Group
41 to 64 years
|
16 Participants
n=5 Participants
|
|
Height
|
167.4 cm
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Weight
|
67.2 kg
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Body Mass Index
|
23.9 kg/m²
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Race
Asian
|
5 participants
n=5 Participants
|
|
Race
Black or African American
|
6 participants
n=5 Participants
|
|
Race
White
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hoursPopulation: Pharmacokinetic (PK) Parameter Set Population includes all subjects from the PK dataset with evaluable PK parameters for each treatment period.
Maximum measured analyte concentration over the sampling period.
Outcome measures
| Measure |
Test: RB Mucinex® ER 600 mg
n=27 Participants
Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
|
Reference: Guaifenesin 200 mg
n=27 Participants
Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
|
1076.37 ng/ml
Standard Deviation 414.80
|
1223.89 ng/ml
Standard Deviation 522.04
|
PRIMARY outcome
Timeframe: 0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hoursPopulation: PK Dataset
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.
Outcome measures
| Measure |
Test: RB Mucinex® ER 600 mg
n=27 Participants
Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
|
Reference: Guaifenesin 200 mg
n=27 Participants
Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Guaifenesin
|
4288.30 ng·h/ml
Standard Deviation 1654.57
|
4641.48 ng·h/ml
Standard Deviation 2211.99
|
SECONDARY outcome
Timeframe: 0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hoursPopulation: PK Dataset
Time of the maximum measured analyte concentration over the sampling period.
Outcome measures
| Measure |
Test: RB Mucinex® ER 600 mg
n=27 Participants
Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
|
Reference: Guaifenesin 200 mg
n=27 Participants
Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
|
|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin
|
0.75 hr
Standard Deviation 0.33
|
1.45 hr
Standard Deviation 2.43
|
SECONDARY outcome
Timeframe: 0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hoursPopulation: PK Dataset
AUCinf = AUCt + Cp/Kel, where Cp is the predicted analyte concentration at the time of the last measurable analyte concentration.
Outcome measures
| Measure |
Test: RB Mucinex® ER 600 mg
n=27 Participants
Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
|
Reference: Guaifenesin 200 mg
n=27 Participants
Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
|
|---|---|---|
|
Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) of Guaifenesin
|
4306.21 ng·h/ml
Standard Deviation 1658.06
|
4647.47 ng·h/ml
Standard Deviation 2212.37
|
SECONDARY outcome
Timeframe: 0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hoursPopulation: PK Dataset
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
Outcome measures
| Measure |
Test: RB Mucinex® ER 600 mg
n=27 Participants
Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
|
Reference: Guaifenesin 200 mg
n=27 Participants
Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
|
|---|---|---|
|
Terminal Elimination Rate Constant (Kel) of Guaifenesin
|
0.4727 1/h
Standard Deviation 0.1711
|
0.7635 1/h
Standard Deviation 0.1011
|
SECONDARY outcome
Timeframe: 0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hoursPopulation: PK Dataset
Terminal elimination half-life, calculated from the equation: T½ = In(2)/Kel.
Outcome measures
| Measure |
Test: RB Mucinex® ER 600 mg
n=27 Participants
Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
|
Reference: Guaifenesin 200 mg
n=27 Participants
Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
|
|---|---|---|
|
Terminal Elimination Half-life (T½) of Guaifenesin
|
1.70 h
Standard Deviation 0.75
|
0.93 h
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: 0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hoursPopulation: Outcome involved analyzing data from both intervention groups (ER and IR) in combination as per the provided formula, therefore, separate analysis for each intervention cannot be reported
RF is measured by (AUCinf ER / AUCinf IR) x (ER dose / IR dose)
Outcome measures
| Measure |
Test: RB Mucinex® ER 600 mg
n=27 Participants
Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
|
Reference: Guaifenesin 200 mg
Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
|
|---|---|---|
|
Relative Bioavailability (RF) of Guaifenesin
|
0.9542 ng·h/ml
Standard Deviation 0.1770
|
—
|
SECONDARY outcome
Timeframe: Up to period 2 (8.3 days/200 hours)Population: Safety population
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 Investigational Medicinal Product (IMP)
Outcome measures
| Measure |
Test: RB Mucinex® ER 600 mg
n=28 Participants
Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
|
Reference: Guaifenesin 200 mg
n=29 Participants
Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
|
|---|---|---|
|
Number of Adverse Events(AEs) Experienced by Participants
TEAE by severity: Mild
|
1 Events
|
9 Events
|
|
Number of Adverse Events(AEs) Experienced by Participants
TEAE by severity: Moderate
|
0 Events
|
0 Events
|
|
Number of Adverse Events(AEs) Experienced by Participants
TEAE by severity: Severe
|
0 Events
|
0 Events
|
|
Number of Adverse Events(AEs) Experienced by Participants
Relationship to IMP: Unassessable/Unclassifiable
|
0 Events
|
3 Events
|
|
Number of Adverse Events(AEs) Experienced by Participants
Relationship to IMP: Conditional /Unclassified
|
0 Events
|
0 Events
|
|
Number of Adverse Events(AEs) Experienced by Participants
Relationship to IMP: Unrelated
|
0 Events
|
0 Events
|
|
Number of Adverse Events(AEs) Experienced by Participants
Relationship to IMP: Unlikely
|
0 Events
|
0 Events
|
|
Number of Adverse Events(AEs) Experienced by Participants
Relationship to IMP: Possible
|
1 Events
|
6 Events
|
|
Number of Adverse Events(AEs) Experienced by Participants
Relationship to IMP: Probable
|
0 Events
|
0 Events
|
|
Number of Adverse Events(AEs) Experienced by Participants
Relationship to IMP: Certain
|
0 Events
|
0 Events
|
Adverse Events
Treatment A: Mucinex® ER 600 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment B: Guaifenesin 200 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A: Mucinex® ER 600 mg
n=28 participants at risk
Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
|
Treatment B: Guaifenesin 200 mg
n=29 participants at risk
Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/28 • Up to 8.3 days (200 hours)
|
3.4%
1/29 • Number of events 1 • Up to 8.3 days (200 hours)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/28 • Up to 8.3 days (200 hours)
|
3.4%
1/29 • Number of events 1 • Up to 8.3 days (200 hours)
|
|
General disorders
Asthenia
|
0.00%
0/28 • Up to 8.3 days (200 hours)
|
3.4%
1/29 • Number of events 1 • Up to 8.3 days (200 hours)
|
|
General disorders
Catheter site bruise
|
0.00%
0/28 • Up to 8.3 days (200 hours)
|
3.4%
1/29 • Number of events 1 • Up to 8.3 days (200 hours)
|
|
General disorders
Catheter site swelling
|
0.00%
0/28 • Up to 8.3 days (200 hours)
|
3.4%
1/29 • Number of events 1 • Up to 8.3 days (200 hours)
|
|
Nervous system disorders
Headache
|
3.6%
1/28 • Number of events 1 • Up to 8.3 days (200 hours)
|
3.4%
1/29 • Number of events 1 • Up to 8.3 days (200 hours)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/28 • Up to 8.3 days (200 hours)
|
3.4%
1/29 • Number of events 1 • Up to 8.3 days (200 hours)
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
0.00%
0/28 • Up to 8.3 days (200 hours)
|
3.4%
1/29 • Number of events 1 • Up to 8.3 days (200 hours)
|
|
Vascular disorders
Hypertension
|
0.00%
0/28 • Up to 8.3 days (200 hours)
|
3.4%
1/29 • Number of events 1 • Up to 8.3 days (200 hours)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place