Trial · NCT03644095
Bioequivalence Study Comparing Mucinex Extended-release 600 mg Tablets to Immediate-release Guaifenesin 600 mg in Healthy Volunteers
NCT03644095, Phase 1, Completed, Reckitt Benckiser Inc.; results first posted 2019-06-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bioequivalence Study Comparing Mucinex Extended-release 600 mg Tablets to Immediate-release Guaifenesin 600 mg in Healthy Volunteers. Trials, record NCT03644095. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03644095
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bioequivalence Study Comparing Mucinex Extended-release 600 mg Tablets to Immediate-release Guaifenesin 600 mg in Healthy Volunteers
- NCT number
- NCT03644095
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 30 participants, actual
- Lead sponsor
- Reckitt Benckiser Inc.
- Conditions
- Healthy Subjects
- Interventions
- Mucinex® SE, Vicks Cough Syrup for Chesty Coughs
- First posted
- 2018-08-23
- Last updated
- 2019-06-19
- Results first posted
- 2019-06-19
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), 0.5, 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 (Cmax) Maximum observed plasma concentration. |
| Primary | Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin | 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 plasma concentration versus time curve from time 0 to the time of the last measurable concentration, as calculated by the linear trapezoidal method. |
| Primary | Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin | 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 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. |
| Primary | Time to Maximum Observed Concentration (Tmax) of Guaifenesin | 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 plasma concentration. |
| Primary | Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin | 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 AUCR is the ratio of AUC(0-t) to AUC(0-inf). AUCR = AUC(0-t) / AUC(0-inf) |
| Primary | Apparent Terminal Elimination Rate Constant (Kel) of Guaifenesin | 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 first-order terminal elimination rate constant calculated from a semi-log 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. 3 or more non-zero plasma concentrations) in the terminal log-linear phase. |
| Primary | Apparent Terminal Elimination Half-life (t1/2) of Guaifenesin | 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 first-order terminal elimination half-life, calculated as ln(2)/kel. |
| Secondary | Number of Adverse Events (AE) of Participants | Upto Day 2 | 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; Probable = Most likely that the AE was caused by study drug; Possible = Reasonable suspicion that the AE was caused by the 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. |
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), 0.5, 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 | The Pharmacokinetic (PK) parameters were calculated from individual plasma concentration-time data (using actual blood draw times). | ng/mL | MEAN |
| PRIMARY | Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin | 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 | PK Data Set | ng*hr/mL | MEAN |
| PRIMARY | Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin | 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 | PK Data Set | ng*hr/mL | MEAN |
| PRIMARY | Time to Maximum Observed Concentration (Tmax) of Guaifenesin | 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 | PK Data Set | hr | MEAN |
| PRIMARY | Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin | 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 | PK Data Set | Ratio | MEAN |
| PRIMARY | Apparent Terminal Elimination Rate Constant (Kel) of Guaifenesin | 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 | PK Data Sets | 1/hr | MEAN |
| PRIMARY | Apparent Terminal Elimination Half-life (t1/2) of Guaifenesin | 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 | PK Data Set | hr | MEAN |
| SECONDARY | Number of Adverse Events (AE) of Participants | Upto Day 2 | Events | NUMBER |
Source ClinicalTrials.gov
Results by group26
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 | Test (Treatment A) | 857 | Standard Deviation 469 | ng/mL | |
| Maximum Observed Plasma Concentration (Cmax) of Guaifenesin | Reference (Treatment B) | 1390 | Standard Deviation 575 | ng/mL | |
| Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin | Test (Treatment A) | 3404.7 | Standard Deviation 1661.1 | ng*hr/mL | |
| Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin | Reference (Treatment B) | 4447.1 | Standard Deviation 1627.4 | ng*hr/mL | |
| Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin | Test (Treatment A) | 3442.0 | Standard Deviation 1674.8 | ng*hr/mL | |
| Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin | Reference (Treatment B) | 4456.4 | Standard Deviation 1630.7 | ng*hr/mL | |
| Time to Maximum Observed Concentration (Tmax) of Guaifenesin | Test (Treatment A) | 0.885 | Standard Deviation 0.537 | hr | |
| Time to Maximum Observed Concentration (Tmax) of Guaifenesin | Reference (Treatment B) | 3.05 | Standard Deviation 2.47 | hr | |
| Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin | Test (Treatment A) | 0.988 | Standard Deviation 0.0144 | Ratio | |
| Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin | Reference (Treatment B) | 0.998 | Standard Deviation 0.00167 | Ratio |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Mucinex First, Then Vicks | 15 | |
| Period 1 | STARTED | Vicks First, Then Mucinex | 15 | |
| Period 1 | COMPLETED | Mucinex First, Then Vicks | 15 | |
| Period 1 | COMPLETED | Vicks First, Then Mucinex | 15 | |
| Period 1 | NOT COMPLETED | Mucinex First, Then Vicks | 0 | |
| Period 1 | NOT COMPLETED | Vicks First, Then Mucinex | 0 | |
| Washout (7 Days) | STARTED | Mucinex First, Then Vicks | 15 | |
| Washout (7 Days) | STARTED | Vicks First, Then Mucinex | 15 | |
| Washout (7 Days) | COMPLETED | Mucinex First, Then Vicks | 15 | |
| Washout (7 Days) | COMPLETED | Vicks First, Then Mucinex | 15 |
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 | Abdominal pain | Gastrointestinal disorders | Test (Treatment A) | 1 | 30 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Reference (Treatment B) | 0 | 30 | 0 |
| other | Constipation | Gastrointestinal disorders | Test (Treatment A) | 1 | 30 | 1 |
| other | Constipation | Gastrointestinal disorders | Reference (Treatment B) | 0 | 30 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | Test (Treatment A) | 0 | 30 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | Reference (Treatment B) | 1 | 30 | 1 |
| other | Skin laceration | Injury, poisoning and procedural complications | Test (Treatment A) | 0 | 30 | 0 |
| other | Skin laceration | Injury, poisoning and procedural complications | Reference (Treatment B) | 1 | 30 | 1 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Test (Treatment A) | 1 | 30 | 1 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Reference (Treatment B) | 0 | 30 | 0 |
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 | Test (Treatment A) | 0 | 30 |
| Total, all-cause mortality | Reference (Treatment B) | 0 | 30 |
| Total, other adverse events | Test (Treatment A) | 5 | 30 |
| Total, other adverse events | Reference (Treatment B) | 6 | 30 |
| Total, serious adverse events | Test (Treatment A) | 0 | 30 |
| Total, serious adverse events | Reference (Treatment B) | 0 | 30 |
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 |
|---|---|
| Test (Treatment A) vs Reference (Treatment B): deaths from any cause | Trial comparisons |
| Test (Treatment A) vs Reference (Treatment B): 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.
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