Trial Outcomes & Findings for Study to Evaluate the Pharmacokinetics of Guaifenesin in Adults and Adolescents (NCT NCT03633448)
NCT ID: NCT03633448
Last Updated: 2019-06-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Results posted on
2019-06-17
Participant Flow
This was a single-centre study.
Total 24 subjects were enrolled in the study and all 24 completed the study.
Participant milestones
| Measure |
200mg Dose of Guaifenesin, Then 400mg Dose of Guaifenesin
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.
|
400mg Dose of Guaifenesin, Then 200mg Dose of Guaifenesin
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 1 (1 Day)
STARTED
|
12
|
12
|
|
Period 1 (1 Day)
COMPLETED
|
12
|
12
|
|
Period 1 (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Washout (7 Days)
STARTED
|
12
|
12
|
|
Washout (7 Days)
COMPLETED
|
12
|
12
|
|
Washout (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (1 Day)
STARTED
|
12
|
12
|
|
Period 2 (1 Day)
COMPLETED
|
12
|
12
|
|
Period 2 (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Pharmacokinetics of Guaifenesin in Adults and Adolescents
Baseline characteristics by cohort
| Measure |
Adolescent
n=12 Participants
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.
|
Adult
n=12 Participants
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
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.3 Years
STANDARD_DEVIATION 1.71 • n=5 Participants
|
32.2 Years
STANDARD_DEVIATION 12.42 • n=7 Participants
|
23.2 Years
STANDARD_DEVIATION 12.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race
Black or African American
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity
Non-Hispanic and Non-Latino
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Height
|
163.9 cm
STANDARD_DEVIATION 7.69 • n=5 Participants
|
166.83 cm
STANDARD_DEVIATION 10.954 • n=7 Participants
|
165.35 cm
STANDARD_DEVIATION 9.379 • n=5 Participants
|
|
Weight
|
56.03 kg
STANDARD_DEVIATION 7.198 • n=5 Participants
|
66.88 kg
STANDARD_DEVIATION 11.611 • n=7 Participants
|
61.45 kg
STANDARD_DEVIATION 10.955 • n=5 Participants
|
|
Body Mass Index
|
20.78 kg/m^2
STANDARD_DEVIATION 1.482 • n=5 Participants
|
23.98 kg/m^2
STANDARD_DEVIATION 3.168 • n=7 Participants
|
22.38 kg/m^2
STANDARD_DEVIATION 2.917 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hoursPopulation: 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.
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.
Outcome measures
| Measure |
Treatment A (Adolescents)
n=12 Participants
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 (Adults)
n=12 Participants
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 (Adolescents)
n=12 Participants
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 (Adults)
n=12 Participants
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.
|
|---|---|---|---|---|
|
Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin
|
1990 ng*hr/mL
Standard Deviation 929
|
1700 ng*hr/mL
Standard Deviation 742
|
4390 ng*hr/mL
Standard Deviation 1590
|
3910 ng*hr/mL
Standard Deviation 1500
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hoursPopulation: PK Data Sets
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.
Outcome measures
| Measure |
Treatment A (Adolescents)
n=12 Participants
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 (Adults)
n=12 Participants
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 (Adolescents)
n=12 Participants
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 (Adults)
n=12 Participants
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.
|
|---|---|---|---|---|
|
Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin
|
2090 ng*hr/mL
Standard Deviation 916
|
1710 ng*hr/mL
Standard Deviation 744
|
4400 ng*hr/mL
Standard Deviation 1600
|
3930 ng*hr/mL
Standard Deviation 1500
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hoursPopulation: PK Data Sets
Percent of AUC 0-inf extrapolated, calculated as (1 - AUC 0-t / AUC 0-inf) x 100.
Outcome measures
| Measure |
Treatment A (Adolescents)
n=12 Participants
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 (Adults)
n=12 Participants
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 (Adolescents)
n=12 Participants
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 (Adults)
n=12 Participants
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.
|
|---|---|---|---|---|
|
Percent of AUC 0-inf Extrapolated (AUC%Extrapolated)
|
0.469 Percentage
Standard Deviation 0.426
|
0.736 Percentage
Standard Deviation 0.775
|
0.476 Percentage
Standard Deviation 0.431
|
0.386 Percentage
Standard Deviation 0.134
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hoursPopulation: PK Data Sets
Pharmacokinetic Parameter (Cmax) Maximum observed plasma concentration.
Outcome measures
| Measure |
Treatment A (Adolescents)
n=12 Participants
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 (Adults)
n=12 Participants
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 (Adolescents)
n=12 Participants
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 (Adults)
n=12 Participants
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.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
|
1360 ng/mL
Standard Deviation 968
|
887 ng/mL
Standard Deviation 419
|
2690 ng/mL
Standard Deviation 1220
|
1950 ng/mL
Standard Deviation 739
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hoursPopulation: PK Data Sets
Pharmacokinetic Parameter (Tmax) Time of the maximum observed plasma concentration.
Outcome measures
| Measure |
Treatment A (Adolescents)
n=12 Participants
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 (Adults)
n=12 Participants
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 (Adolescents)
n=12 Participants
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 (Adults)
n=12 Participants
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.
|
|---|---|---|---|---|
|
Time to Maximum Observed Concentration (Tmax) of Guaifenesin
|
0.458 hr
Standard Deviation 0.209
|
0.711 hr
Standard Deviation 0.403
|
0.524 hr
Standard Deviation 0.325
|
0.646 hr
Standard Deviation 0.345
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hoursPopulation: PK Data Sets
Apparent first-order terminal elimination half-life, calculated as ln(2)/kel.
Outcome measures
| Measure |
Treatment A (Adolescents)
n=12 Participants
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 (Adults)
n=12 Participants
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 (Adolescents)
n=12 Participants
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 (Adults)
n=12 Participants
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.
|
|---|---|---|---|---|
|
Apparent First-order Terminal Elimination Half-life (t½)
|
1.05 hr
Standard Deviation 0.173
|
1.10 hr
Standard Deviation 0.228
|
0.963 hr
Standard Deviation 0.129
|
0.963 hr
Standard Deviation 0.0899
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hoursPopulation: PK Data Sets
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.
Outcome measures
| Measure |
Treatment A (Adolescents)
n=12 Participants
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 (Adults)
n=12 Participants
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 (Adolescents)
n=12 Participants
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 (Adults)
n=12 Participants
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.
|
|---|---|---|---|---|
|
Apparent First-order Terminal Elimination Rate Constant (Kel)
|
0.678 1/hr
Standard Deviation 0.100
|
0.655 1/hr
Standard Deviation 0.122
|
0.731 1/hr
Standard Deviation 0.0928
|
0.726 1/hr
Standard Deviation 0.0757
|
SECONDARY outcome
Timeframe: Upto Day 1Population: PK Data Sets
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.
Outcome measures
| Measure |
Treatment A (Adolescents)
n=12 Participants
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 (Adults)
n=12 Participants
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 (Adolescents)
n=12 Participants
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 (Adults)
n=12 Participants
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.
|
|---|---|---|---|---|
|
Number of Adverse Events (AEs) of Participants
TEAE by severity: Mild
|
0 Events
|
0 Events
|
0 Events
|
1 Events
|
|
Number of Adverse Events (AEs) of Participants
TEAE by severity: Moderate
|
0 Events
|
0 Events
|
0 Events
|
1 Events
|
|
Number of Adverse Events (AEs) of Participants
TEAE by severity: Severe
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Number of Adverse Events (AEs) of Participants
Relationship to Drug: Definite
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Number of Adverse Events (AEs) of Participants
Relationship to Drug: Probable
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Number of Adverse Events (AEs) of Participants
Relationship to Drug: Possible
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Number of Adverse Events (AEs) of Participants
Relationship to Drug: Unlikely
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Number of Adverse Events (AEs) of Participants
Relationship to Drug: None
|
0 Events
|
0 Events
|
0 Events
|
2 Events
|
Adverse Events
Treatment A (Adolescents)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment A (Adults)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment B (Adolescents)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment B (Adults)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A (Adolescents)
n=12 participants at risk
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 (Adults)
n=12 participants at risk
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 (Adolescents)
n=12 participants at risk
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 (Adults)
n=12 participants at risk
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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • Up to Day 14
|
0.00%
0/12 • Up to Day 14
|
0.00%
0/12 • Up to Day 14
|
8.3%
1/12 • Number of events 1 • Up to Day 14
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • Up to Day 14
|
0.00%
0/12 • Up to Day 14
|
0.00%
0/12 • Up to Day 14
|
8.3%
1/12 • Number of events 1 • Up to Day 14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place