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Trial Outcomes & Findings for Study to Evaluate the Pharmacokinetics of Mucinex® 1200 mg Extended-Release Tablet (NCT NCT03633487)

NCT ID: NCT03633487

Last Updated: 2019-02-28

Results Overview

Pharmacokinetic Parameters (Cmax) Maximum observed plasma concentration.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1

Results posted on

2019-02-28

Participant Flow

This was a single-centre study.

A total of 24 subjects entered the study; All 24 subjects were included single-period.

Participant milestones

Participant milestones
Measure
Mucinex® 1200 mg
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Overall Study
STARTED
24
Overall Study
COMPLETED
24
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate the Pharmacokinetics of Mucinex® 1200 mg Extended-Release Tablet

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Mucinex® 1200 mg
n=24 Participants
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Age, Continuous
30.4 years
STANDARD_DEVIATION 10.95 • n=5 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants
Sex: Female, Male
Male
17 Participants
n=5 Participants
Race
Asian
1 participants
n=5 Participants
Race
Black or African American
1 participants
n=5 Participants
Race
White
22 participants
n=5 Participants
Ethnicity
Hispanic or Latino
2 participants
n=5 Participants
Ethnicity
Not Hispanic or Latino
22 participants
n=5 Participants
Weight
75.42 kg
STANDARD_DEVIATION 12.711 • n=5 Participants
Height
175.8 cm
STANDARD_DEVIATION 9.65 • n=5 Participants
Body Mass Index
24.220 kg/m²
STANDARD_DEVIATION 2.4480 • n=5 Participants

PRIMARY outcome

Timeframe: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1

Population: Pharmacokinetic (PK) population includes subjects with at least one PK sample. Available data from any subjects who vomited within 12 hours after dosing were to be included in the PK data sets.

Pharmacokinetic Parameters (Cmax) Maximum observed plasma concentration.

Outcome measures

Outcome measures
Measure
Mucinex® 1200 mg
n=24 Participants
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Maximum Observed Plasma Concentration (Cmax)
1634 ng/mL
Standard Deviation 769.95

PRIMARY outcome

Timeframe: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1

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

Outcome measures

Outcome measures
Measure
Mucinex® 1200 mg
n=24 Participants
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Time of the Maximum Observed Plasma Concentration (Tmax)
0.9753 hr
Standard Deviation 0.61407

PRIMARY outcome

Timeframe: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1

Pharmacokinetic Parameter (AUC0-t) is Area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration

Outcome measures

Outcome measures
Measure
Mucinex® 1200 mg
n=24 Participants
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t)
6515.5 ng*hr/mL
Standard Deviation 2765.33

PRIMARY outcome

Timeframe: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1

Pharmacokinetic Parameter (AUC0-inf) Area under the plasma concentration versus time curve from time 0 to infinity.

Outcome measures

Outcome measures
Measure
Mucinex® 1200 mg
n=23 Participants
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf)
6733.5 ng*hr/mL
Standard Deviation 2831.57

PRIMARY outcome

Timeframe: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1

Pharmacokinetic Parameter (AUC%extrap) Percent of AUC0-inf extrapolated AUCR = 100 - (AUC0-t/ AUC0-inf) x 100

Outcome measures

Outcome measures
Measure
Mucinex® 1200 mg
n=23 Participants
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Percentage of AUC0-inf Extrapolated Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin
1.950 Percentage of AUC0-inf extrapolated AUCR
Standard Deviation 2.7458

PRIMARY outcome

Timeframe: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1

Pharmacokinetic Parameter (Kel) Apparent first-order terminal elimination rate constant

Outcome measures

Outcome measures
Measure
Mucinex® 1200 mg
n=23 Participants
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Apparent First-order Terminal Elimination Rate Constant (Kel)
0.2644 1/hr
Standard Deviation 0.16374

PRIMARY outcome

Timeframe: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1

Pharmacokinetic Parameter (t1/2) is Apparent terminal elimination half-life.

Outcome measures

Outcome measures
Measure
Mucinex® 1200 mg
n=23 Participants
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Terminal Elimination Half Life (t1/2)
3.374 hr
Standard Deviation 1.6383

PRIMARY outcome

Timeframe: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1

Pharmacokinetic Parameter (T65) is te time when guaifenesin plasma concentration achieved a target concentration of at least 65 ng/mL.

Outcome measures

Outcome measures
Measure
Mucinex® 1200 mg
n=24 Participants
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Time at Which the Percentage of Subjects Achieved a Target Concentration of at Least 65 ng/mL (T65)
0.1999 hr
Standard Deviation 0.10427

SECONDARY outcome

Timeframe: Up to Day 2

Intensity was determined by the Investigator. For symptomatic adverse events (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® 1200 mg
n=24 Participants
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
TEAE by severity: Mild
3 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 - Definite
0 Participants
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
Relationship to IMP - Probable
0 Participants
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
Relationship to IMP - Possible
1 Participants
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
Relationship to IMP - Unlikely
0 Participants
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
Relationship to IMP - None
2 Participants

Adverse Events

Mucinex® 1200 mg

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Mucinex® 1200 mg
n=24 participants at risk
Single dose Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet by mouth.
General disorders
Catheter site swelling
4.2%
1/24 • Number of events 1 • Up to Day 2
General disorders
Oedema peripheral
4.2%
1/24 • Number of events 1 • Up to Day 2
Nervous system disorders
Headache
4.2%
1/24 • Number of events 1 • Up to Day 2
Nervous system disorders
Presyncope
4.2%
1/24 • 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