NCT03644108

Study to Evaluate the Pharmacokinetics of Mucinex 600 mg Extended-release Bi-layer Tablet in Healthy Volunteers

Completed Phase 1 Results posted Last updated 28 February 2019

What this trial tests

Phase 1 trial testing Mucinex® ER 600 mg in Healthy Subjects in 30 participants. Completed in 15 June 2009.

Timeline

4 June 2009

Primary endpoint
15 June 2009

15 June 2009

Quick facts

Lead sponsor	Reckitt Benckiser Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	30
Start date	4 June 2009
Primary completion	15 June 2009
Estimated completion	15 June 2009

Drugs / interventions tested

• Mucinex® ER 600 mg — full drug profile →

Conditions studied

• Healthy Subjects — all drugs for Healthy Subjects →

Sponsor

Reckitt Benckiser Inc. — full company profile →

Who can join

Adults 19 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.

Maximum Observed Plasma Concentration (Cmax) of Guaifenesin Primary · 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

Pharmacokinetic Parameters Cmax (Maximum observed drug concentration)

Group	Value	95% CI
Mucinex® 600 mg ER	876	± 45.1

Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin Primary · 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

Area under the drug concentration-time curve calculated using linear trapezoidal summation from time zero to time t, where t is the time of the last measurable concentration (Ct).

Group	Value	95% CI
Mucinex® 600 mg ER	3670	± 45.4

Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin Primary · 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

Area under the drug concentration-time curve from time zero to infinity, AUC(0-inf) = AUC(0-t) + Ct/Kel, where Kel is the terminal elimination rate constant.

Group	Value	95% CI
Mucinex® 600 mg ER	3694	± 45.2

Time to Maximum Observed Concentration (Tmax) of Guaifenesin Primary · 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

Pharmacokinetic Parameter tmax (Time of the maximum observed drug concentration).

Group	Value	95% CI
Mucinex® 600 mg ER	0.752	0.498 – 2.00

Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin Primary · 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

Ratio of AUC(0-t) to AUC(0-inf), referred to as AUCR. \[AUCR = AUC(0-t) / AUC(0-inf)\]

Group	Value	95% CI
Mucinex® 600 mg ER	0.9934	± 0.007125

Apparent Terminal Elimination Rate Constant (Kel) of Guaifenesin Primary · 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

Apparent terminal elimination rate constant (Kel) calculated by linear regression of the terminal linear portion of the log concentration-time curve.

Group	Value	95% CI
Mucinex® 600 mg ER	0.455	± 0.200

Apparent Terminal Elimination Half-life (t1/2) of Guaifenesin Primary · 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

Apparent terminal elimination half-life (t1/2) calculated as ln(2)/Kel.

Group	Value	95% CI
Mucinex® 600 mg ER	1.91	± 1.11

Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Secondary · Up to Day 2

Intensity was determined by the Investigator. For symptomatic 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 tha

TEAE by severity: Mild

Group	Value	95% CI
Mucinex® 600 mg ER	5

TEAE by severity: Moderate

Group	Value	95% CI
Mucinex® 600 mg ER	0

TEAE by severity: Severe

Group	Value	95% CI
Mucinex® 600 mg ER	0

Relationship to IMP - Unlikely

Group	Value	95% CI
Mucinex® 600 mg ER	5

Relationship to IMP - Possible

Group	Value	95% CI
Mucinex® 600 mg ER	0

Relationship to IMP - Probable

Group	Value	95% CI
Mucinex® 600 mg ER	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Day 2. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mucinex® 600 mg ER

Serious: 0/30 (0%)

Deaths: 5/30

Other adverse events (2 terms — click to expand)

Reaction	System	Mucinex® 600 mg ER
Headache	Nervous system disorders	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—

Data from ClinicalTrials.gov NCT03644108 adverse events section.

Sponsor's own description

Evaluate the Pharmacokinetics of Mucinex® 600 mg Extended-Release Bi-Layer Tablet in Normal Healthy Subjects

Publications & conference data

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