NCT03633448

Study to Evaluate the Pharmacokinetics of Guaifenesin in Adults and Adolescents

Completed Phase 1 Results posted Last updated 17 June 2019

What this trial tests

Phase 1 trial testing Children's Mucinex® Grape Flavor in Healthy Subjects in 24 participants. Completed in 1 July 2011.

Timeline

18 June 2011

Primary endpoint
1 July 2011

1 July 2011

Quick facts

Lead sponsor	Reckitt Benckiser LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	24
Start date	18 June 2011
Primary completion	1 July 2011
Estimated completion	1 July 2011

Drugs / interventions tested

• Children's Mucinex® Grape Flavor — full drug profile →
• Children's Mucinex® Grape Flavor — full drug profile →

Conditions studied

• Healthy Subjects — all drugs for Healthy Subjects →

Sponsor

Reckitt Benckiser LLC — full company profile →

Who can join

Adults 12 to 55, any sex, with Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin Primary · 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours

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.

Group	Value	95% CI
Treatment A (Adolescents)	1990	± 929
Treatment A (Adults)	1700	± 742
Treatment B (Adolescents)	4390	± 1590
Treatment B (Adults)	3910	± 1500

Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin Primary · 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours

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.

Group	Value	95% CI
Treatment A (Adolescents)	2090	± 916
Treatment A (Adults)	1710	± 744
Treatment B (Adolescents)	4400	± 1600
Treatment B (Adults)	3930	± 1500

Percent of AUC 0-inf Extrapolated (AUC%Extrapolated) Primary · 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours

Percent of AUC 0-inf extrapolated, calculated as (1 - AUC 0-t / AUC 0-inf) x 100.

Group	Value	95% CI
Treatment A (Adolescents)	0.469	± 0.426
Treatment A (Adults)	0.736	± 0.775
Treatment B (Adolescents)	0.476	± 0.431
Treatment B (Adults)	0.386	± 0.134

Maximum Observed Plasma Concentration (Cmax) of Guaifenesin Primary · 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours

Pharmacokinetic Parameter (Cmax) Maximum observed plasma concentration.

Group	Value	95% CI
Treatment A (Adolescents)	1360	± 968
Treatment A (Adults)	887	± 419
Treatment B (Adolescents)	2690	± 1220
Treatment B (Adults)	1950	± 739

Time to Maximum Observed Concentration (Tmax) of Guaifenesin Primary · 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours

Pharmacokinetic Parameter (Tmax) Time of the maximum observed plasma concentration.

Group	Value	95% CI
Treatment A (Adolescents)	0.458	± 0.209
Treatment A (Adults)	0.711	± 0.403
Treatment B (Adolescents)	0.524	± 0.325
Treatment B (Adults)	0.646	± 0.345

Apparent First-order Terminal Elimination Half-life (t½) Primary · 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours

Apparent first-order terminal elimination half-life, calculated as ln(2)/kel.

Group	Value	95% CI
Treatment A (Adolescents)	1.05	± 0.173
Treatment A (Adults)	1.10	± 0.228
Treatment B (Adolescents)	0.963	± 0.129
Treatment B (Adults)	0.963	± 0.0899

Apparent First-order Terminal Elimination Rate Constant (Kel) Primary · 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours

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.

Group	Value	95% CI
Treatment A (Adolescents)	0.678	± 0.100
Treatment A (Adults)	0.655	± 0.122
Treatment B (Adolescents)	0.731	± 0.0928
Treatment B (Adults)	0.726	± 0.0757

Number of Adverse Events (AEs) of Participants Secondary · Upto Day 1

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 cau

TEAE by severity: Mild

Group	Value	95% CI
Treatment A (Adolescents)	0
Treatment A (Adults)	0
Treatment B (Adolescents)	0
Treatment B (Adults)	1

TEAE by severity: Moderate

Group	Value	95% CI
Treatment A (Adolescents)	0
Treatment A (Adults)	0
Treatment B (Adolescents)	0
Treatment B (Adults)	1

TEAE by severity: Severe

Group	Value	95% CI
Treatment A (Adolescents)	0
Treatment A (Adults)	0
Treatment B (Adolescents)	0
Treatment B (Adults)	0

Relationship to Drug: Definite

Group	Value	95% CI
Treatment A (Adolescents)	0
Treatment A (Adults)	0
Treatment B (Adolescents)	0
Treatment B (Adults)	0

Relationship to Drug: Probable

Group	Value	95% CI
Treatment A (Adolescents)	0
Treatment A (Adults)	0
Treatment B (Adolescents)	0
Treatment B (Adults)	0

Relationship to Drug: Possible

Group	Value	95% CI
Treatment A (Adolescents)	0
Treatment A (Adults)	0
Treatment B (Adolescents)	0
Treatment B (Adults)	0

Relationship to Drug: Unlikely

Group	Value	95% CI
Treatment A (Adolescents)	0
Treatment A (Adults)	0
Treatment B (Adolescents)	0
Treatment B (Adults)	0

Relationship to Drug: None

Group	Value	95% CI
Treatment A (Adolescents)	0
Treatment A (Adults)	0
Treatment B (Adolescents)	0
Treatment B (Adults)	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Day 14. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment A (Adolescents)

Serious: 0/12 (0%)

Deaths: 0/12

Treatment A (Adults)

Serious: 0/12 (0%)

Deaths: 0/12

Treatment B (Adolescents)

Serious: 0/12 (0%)

Deaths: 0/12

Treatment B (Adults)

Serious: 0/12 (0%)

Deaths: 1/12

Other adverse events (2 terms — click to expand)

Reaction	System	Treatment A (Adolescents)	Treatment A (Adults)	Treatment B (Adolescents)	Treatment B (Adults)
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—

Data from ClinicalTrials.gov NCT03633448 adverse events section.

Sponsor's own description

Evaluate the pharmacokinetics (PK), Safety and tolerability of guaifenesin (Mucinex®) in an immediate-release formulation when a single dose is administered in adolescents and in adults when compared to Children.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.