Trial · NCT03649750
Mucinex® ER 600 mg Bi-Layer Tablet Fed and Fasted
NCT03649750, Phase 1, Completed, Reckitt Benckiser LLC; results first posted 2019-02-22
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Mucinex® ER 600 mg Bi-Layer Tablet Fed and Fasted. Trials, record NCT03649750. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03649750
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mucinex® ER 600 mg Bi-Layer Tablet Fed and Fasted
- NCT number
- NCT03649750
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 36 participants, actual
- Lead sponsor
- Reckitt Benckiser LLC
- Conditions
- Healthy Subjects
- Interventions
- Mucinex®
- First posted
- 2018-08-28
- Last updated
- 2019-03-27
- Results first posted
- 2019-02-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Guaifenesin | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) | Maximum measured analyte concentration over the sampling period. |
| Primary | Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Plasma Concentration (AUCt) of Guaifenesin | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) | The area under the analyte concentration versus time curve, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear trapezoidal method. |
| Secondary | Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) | Time of the maximum measured analyte concentration over the sampling period. |
| Secondary | Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) of Guaifenesin | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) | The area under the analyte concentration versus time curve from time zero to infinity. AUCinf = AUCt + Cp/Kel, where Cp is the predicted analyte concentration at the time of the last measurable analyte concentration. |
| Secondary | Terminal Elimination Rate Constant (Kel) of Guaifenesin | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) | Elimination rate constant calculated from the slope of the terminal portion of the plasma profile calculated by least-squares regression of log (concentration) versus time. |
| Secondary | Terminal Elimination Half-life (T½) of Guaifenesin | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) | Terminal elimination half-life, calculated from the equation: thalf = In(2)/Kel. |
| Secondary | Relative Bioavailability (RF) of Guaifenesin | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) | Relative bioavailability for each formulation will be defined as: (AUC0-inf Fasting ÷ AUC0-inf Fed) x (Fed dose ÷ Fasting dose) |
| Secondary | Number of Adverse Events(AEs) Experienced by Participants | Up to period 2 (8.3 days/200 hours) | 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 Unassessable/Unclassifiable=Insufficient information to be able to make an assessment Conditional/Unclassified=Insufficient information to make an assessment at present(causality is conditional on additional information) Unrelated=No possibility that the AE was caused by study drug 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 Certain=The AE was definitely caused by study drug |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of Guaifenesin | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) | Pharmacokinetic (PK) Dataset are the Subjects from whom the observation/estimation of Cmax and AUC measures/parameters will be possible for two periods will be included in the PK dataset.~The PK dataset will be defined prior to the assay of samples. | ng/ml | MEAN |
| PRIMARY | Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Plasma Concentration (AUCt) of Guaifenesin | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) | Pharmacokinetic Dataset | ng·h/ml | MEAN |
| SECONDARY | Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) | Pharmacokinetic Dataset | h | MEAN |
| SECONDARY | Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) of Guaifenesin | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) | Pharmacokinetic Dataset | ng·h/ml | MEAN |
| SECONDARY | Terminal Elimination Rate Constant (Kel) of Guaifenesin | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) | Pharmacokinetic Dataset | 1/h | MEAN |
| SECONDARY | Terminal Elimination Half-life (T½) of Guaifenesin | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) | Pharmacokinetic Dataset | h | MEAN |
| SECONDARY | Relative Bioavailability (RF) of Guaifenesin | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) | Outcome involved analyzing data from both intervention groups (Fed and Fasting) in combination as per the provided formula, therefore, separate analysis for each intervention cannot be reported | Percent bioavailability | MEAN |
| SECONDARY | Number of Adverse Events(AEs) Experienced by Participants | Up to period 2 (8.3 days/200 hours) | Pharmacokinetic Dataset~Investigational Medicinal Product(IMP) | Events | NUMBER |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Guaifenesin | Treatment A: Mucinex® 600 mg (Fast) | 1066.11 | Standard Deviation 429.91 | ng/ml | |
| Maximum Observed Plasma Concentration (Cmax) of Guaifenesin | Treatment B: Mucinex® 600 mg (Fed) | 1117.31 | Standard Deviation 424.82 | ng/ml | |
| Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Plasma Concentration (AUCt) of Guaifenesin | Treatment A: Mucinex® 600 mg (Fast) | 4052.10 | Standard Deviation 1495.48 | ng·h/ml | |
| Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Plasma Concentration (AUCt) of Guaifenesin | Treatment B: Mucinex® 600 mg (Fed) | 4084.90 | Standard Deviation 1380.20 | ng·h/ml | |
| Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin | Treatment A: Mucinex® 600 mg (Fast) | 0.68 | Standard Deviation 0.32 | h | |
| Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin | Treatment B: Mucinex® 600 mg (Fed) | 3.33 | Standard Deviation 1.36 | h | |
| Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) of Guaifenesin | Treatment A: Mucinex® 600 mg (Fast) | 4104.47 | Standard Deviation 1555.87 | ng·h/ml | |
| Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) of Guaifenesin | Treatment B: Mucinex® 600 mg (Fed) | 4092.53 | Standard Deviation 1382.77 | ng·h/ml | |
| Terminal Elimination Rate Constant (Kel) of Guaifenesin | Treatment A: Mucinex® 600 mg (Fast) | 0.3862 | Standard Deviation 0.1717 | 1/h | |
| Terminal Elimination Rate Constant (Kel) of Guaifenesin | Treatment B: Mucinex® 600 mg (Fed) | 0.6788 | Standard Deviation 0.1343 | 1/h |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Cohort 1(Mucinex Fed or Mucinex Fast in Period 1 and Period 2) | 12 | |
| Period 1 | STARTED | Cohort 2(Mucinex Fast or Mucinex Fed in Period 1 and Period 2) | 24 | |
| Period 1 | COMPLETED | Cohort 1(Mucinex Fed or Mucinex Fast in Period 1 and Period 2) | 12 | |
| Period 1 | COMPLETED | Cohort 2(Mucinex Fast or Mucinex Fed in Period 1 and Period 2) | 24 | |
| Period 1 | NOT COMPLETED | Cohort 1(Mucinex Fed or Mucinex Fast in Period 1 and Period 2) | 0 | |
| Period 1 | NOT COMPLETED | Cohort 2(Mucinex Fast or Mucinex Fed in Period 1 and Period 2) | 0 | |
| Washout: 7 Days | STARTED | Cohort 1(Mucinex Fed or Mucinex Fast in Period 1 and Period 2) | 12 | |
| Washout: 7 Days | STARTED | Cohort 2(Mucinex Fast or Mucinex Fed in Period 1 and Period 2) | 24 | |
| Washout: 7 Days | COMPLETED | Cohort 1(Mucinex Fed or Mucinex Fast in Period 1 and Period 2) | 12 | |
| Washout: 7 Days | COMPLETED | Cohort 2(Mucinex Fast or Mucinex Fed in Period 1 and Period 2) | 24 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tachycardia | Cardiac disorders | Treatment A: Mucinex® 600 mg (Fast) | 1 | 36 | 1 |
| other | Tachycardia | Cardiac disorders | Treatment B: Mucinex® 600 mg (Fed) | 0 | 36 | 0 |
| other | Abdominal pain lower | Gastrointestinal disorders | Treatment A: Mucinex® 600 mg (Fast) | 1 | 36 | 1 |
| other | Abdominal pain lower | Gastrointestinal disorders | Treatment B: Mucinex® 600 mg (Fed) | 0 | 36 | 0 |
| other | Vessel puncture site bruise | General disorders | Treatment A: Mucinex® 600 mg (Fast) | 0 | 36 | 0 |
| other | Vessel puncture site bruise | General disorders | Treatment B: Mucinex® 600 mg (Fed) | 1 | 36 | 1 |
| other | Vessel puncture site pain | General disorders | Treatment A: Mucinex® 600 mg (Fast) | 0 | 36 | 0 |
| other | Vessel puncture site pain | General disorders | Treatment B: Mucinex® 600 mg (Fed) | 1 | 36 | 1 |
| other | Vessel puncture site swelling | General disorders | Treatment A: Mucinex® 600 mg (Fast) | 0 | 36 | 0 |
| other | Vessel puncture site swelling | General disorders | Treatment B: Mucinex® 600 mg (Fed) | 1 | 36 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment A: Mucinex® 600 mg (Fast) | 0 | 36 |
| Total, all-cause mortality | Treatment B: Mucinex® 600 mg (Fed) | 0 | 36 |
| Total, other adverse events | Treatment A: Mucinex® 600 mg (Fast) | 8 | 36 |
| Total, other adverse events | Treatment B: Mucinex® 600 mg (Fed) | 10 | 36 |
| Total, serious adverse events | Treatment A: Mucinex® 600 mg (Fast) | 0 | 36 |
| Total, serious adverse events | Treatment B: Mucinex® 600 mg (Fed) | 0 | 36 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment A: Mucinex® 600 mg (Fast) vs Treatment B: Mucinex® 600 mg (Fed): deaths from any cause | Trial comparisons |
| Treatment A: Mucinex® 600 mg (Fast) vs Treatment B: Mucinex® 600 mg (Fed): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03649750
GET https://conductscience.org/api/trials/v1/NCT03649750/results?page=2