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Trial Outcomes & Findings for Study to Evaluate the Pharmacokinetics of Mucinex 600 mg Extended-release Bi-layer Tablet in Healthy Volunteers (NCT NCT03644108)

NCT ID: NCT03644108

Last Updated: 2019-02-28

Results Overview

Pharmacokinetic Parameters Cmax (Maximum observed drug concentration)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

30 participants

Primary outcome timeframe

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

Results posted on

2019-02-28

Participant Flow

This was a single-centre study.

A total of 30 subjects were screened for the study; All 30 subjects were included single-period.

Participant milestones

Participant milestones
Measure
Mucinex® 600 mg ER
Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Overall Study
STARTED
30
Overall Study
COMPLETED
30
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Mucinex® 600 mg ER
n=30 Participants
Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Age, Continuous
26.3 years
STANDARD_DEVIATION 6.97 • n=5 Participants
Sex: Female, Male
Female
15 Participants
n=5 Participants
Sex: Female, Male
Male
15 Participants
n=5 Participants
Race
Asian
1 Participants
n=5 Participants
Race
Black
2 Participants
n=5 Participants
Race
Caucasian
27 Participants
n=5 Participants
Weight
160.4 lb
STANDARD_DEVIATION 23.11 • n=5 Participants
Height
68.41 in
STANDARD_DEVIATION 3.222 • n=5 Participants
Body Mass Index
23.976 kg/m^2
STANDARD_DEVIATION 1.8368 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Population: Data Sets Analyzed as all 30 subjects were included in the guaifenesin concentration tables and the calculation of guaifenesin Pharmacokinetic (PK) parameters.

Pharmacokinetic Parameters Cmax (Maximum observed drug concentration)

Outcome measures

Outcome measures
Measure
Mucinex® 600 mg ER
n=30 Participants
Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
876 ng/mL
Geometric Coefficient of Variation 45.1

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Mucinex® 600 mg ER
n=30 Participants
Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin
3670 ng∙hr/mL
Geometric Coefficient of Variation 45.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mucinex® 600 mg ER
n=30 Participants
Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin
3694 ng∙hr/mL
Geometric Coefficient of Variation 45.2

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Mucinex® 600 mg ER
n=30 Participants
Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Time to Maximum Observed Concentration (Tmax) of Guaifenesin
0.752 hr
Interval 0.498 to 2.0

PRIMARY outcome

Timeframe: 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. \[AUCR = AUC(0-t) / AUC(0-inf)\]

Outcome measures

Outcome measures
Measure
Mucinex® 600 mg ER
n=30 Participants
Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin
0.9934 Ratio
Standard Deviation 0.007125

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mucinex® 600 mg ER
n=30 Participants
Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Apparent Terminal Elimination Rate Constant (Kel) of Guaifenesin
0.455 1/hr
Standard Deviation 0.200

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mucinex® 600 mg ER
n=30 Participants
Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Apparent Terminal Elimination Half-life (t1/2) of Guaifenesin
1.91 hr
Standard Deviation 1.11

SECONDARY outcome

Timeframe: 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 that the AE was caused by IMP. Probable = Most likely that AE was caused by IMP.

Outcome measures

Outcome measures
Measure
Mucinex® 600 mg ER
n=30 Participants
Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
TEAE by severity: Mild
5 Participants
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
TEAE by severity: Moderate
0 Participants
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
TEAE by severity: Severe
0 Participants
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Relationship to IMP - Unlikely
5 Participants
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Relationship to IMP - Possible
0 Participants
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Relationship to IMP - Probable
0 Participants

Adverse Events

Mucinex® 600 mg ER

Serious events: 0 serious events
Other events: 5 other events
Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Mucinex® 600 mg ER
n=30 participants at risk
Single dose Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet expectorant by mouth.
Nervous system disorders
Headache
13.3%
4/30 • Number of events 4 • Up to Day 2
Respiratory, thoracic and mediastinal disorders
Nasal congestion
3.3%
1/30 • Number of events 1 • Up to Day 2

Additional Information

Clinical Research Director, Clinical Research

Reckitt Benckiser, Inc

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place