Mucinex® ER 600 mg Bi-Layer Tablet Fed and Fasted

• Sponsor: Reckitt Benckiser LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03649750
• Collaborator: (none)
• Enrollment: 36
• Arms: 2
• Actual Duration (Months): 2.3

Study Details

Study Description

Brief Summary

Determine and compare the plasma concentrations of Mucinex® Extended Release (ER) 600 mg bi-layer tablet in normal healthy volunteers in fed and fasting conditions

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: Mucinex®	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase I, Open-label, Single-dose, Randomized, 2-way Cross-over Study Designed to Examine the Relative Bioavailability of Guaifenesin When a Mucinex Extended Release 600 mg Bi-layer Tablet is Taken Under Fasted Compared to Fed Conditions in Normal Healthy Volunteers
• Actual Study Start Date: May 29, 2013
• Actual Primary Completion Date: Aug 7, 2013
• Actual Study Completion Date: Aug 7, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A: Mucinex® 600 mg (fast) Mucinex® 600 mg ER bi-layer tablet by mouth after 10 hours fasting and subject will fast at least 4 hours post-dose	Drug: Mucinex®; Mucinex® 600 mg ER bi-layer tablets; Other Names: guaifenesin
Experimental: Treatment B: Mucinex® 600 mg (fed) Mucinex® 600 mg ER bi-layer tablet by mouth in fed condition. After an overnight fast of at least 10 hours, subjects will consume a high fat, high calorie breakfast starting 30 minutes prior to drug administration	Drug: Mucinex®; Mucinex® 600 mg ER bi-layer tablets; Other Names: guaifenesin

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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)

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Informed consent was obtained (i.e. be informed of the nature of the study and given written consent prior to any study procedure). Able to read, understand, and sign the informed consent, after the nature of the study had been explained.

2. Age: 18 to 55 years of age, inclusive.

3. Sex: male or female.

4. Status: Healthy subjects.

5. BMI: ≥18.0 and ≤28.0 kg/m2.

6. No clinically significant findings in vital signs measurements at screening.

7. No clinically significant abnormal laboratory values at screening.

8. No clinically significant findings from a 12-lead electrocardiogram (ECG) at screening.

9. Had no significant diseases or clinically relevant medical condition in the opinion of the Investigator

10. Males who participated in this study were willing to:

• remain abstinent [not engage in sexual intercourse] from the start of drug administration until 90 days after the end of the study or

• used (or their partner used, as applicable) two effective methods of birth control [condom, diaphragm, cervical cap, vaginal sponge, spermicide, IUD, tubal ligation, vasectomy, or hormonal contraceptives] from the start of drug administration until 90 days after the end of the study.

Females who participated in this study were:

• unable to have children (e.g., post-menopausal, hysterectomy);

• willing to remain abstinent [not engage in sexual intercourse] from 21 days prior to drug administration until 30 days after the end of the study; or

• willing to use two effective methods of birth control [condom, diaphragm, cervical cap, vaginal sponge, spermicide, non-hormonal Intrauterine Device (IUD) (in place for 3 months), tubal ligation, partner has vasectomy, hormonal contraceptives for 3 months prior to drug administration] from 30 days prior to drug administration until 30 days after the end of the study.

1. Had no clinically significant findings from a physical examination.

Exclusion Criteria:

1. Employee of Pharma Medica Research Inc. (PMRI) or Reckitt Benckiser.

2. Partner or first-degree relative of any Investigator at PMRI.

3. Known history or presence of any clinically significant medical condition.

4. Known or suspected carcinoma.

5. Presence of hepatic or renal dysfunction.

6. Presence of clinically significant gastrointestinal disease or history of malabsorption within the year preceding the study.

7. Known history or presence of galactose or fructose intolerance, sucrase-isomaltase insufficiency, Lapp lactase insufficiency, galactosemia, or glucose-galactose malabsorption syndrome.

8. Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.

9. History of drug or alcohol or medicinal product addiction requiring treatment within the two years preceding the study or excessive alcohol consumption (more than 10 units per week)

Note: one unit is defined as 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of spirits.

1. Positive test result for serum Human Chorionic Gonadotropin (hCG) consistent with pregnancy (females only), HIV, Hepatitis B surface antigen or Hepatitis C antibody.

2. Positive test result for urine drugs of abuse (cannabinoids, opiates, amphetamines, cocaine, phencyclidine, tricyclic antidepressants, barbiturates, methadone and benzodiazepines) or urine cotinine.

3. Difficulty fasting or consuming standard meals.

4. Females who were lactating.

5. Did not tolerate venipuncture.

6. Use of tobacco or nicotine-containing products within 12 months prior to drug administration.

7. On a special diet within 30 days prior to drug administration (e.g., liquid, protein, raw food diet).

8. Donation or loss of whole blood (including clinical trials):

• ≥50 ml and ≤499 ml within 30 days prior to drug administration

• ≥500 ml within 56 days prior to drug administration

1. Females who had started taking hormonal contraceptives or had changed their method or brand of hormonal birth control within 3 months prior to drug administration.

2. Had a tattoo or body piercing within 30 days prior to drug administration.

3. Use of drugs of the monoamine oxidase inhibitor (MAOI) class within 30 days prior to drug administration.

4. Known history or presence of hypersensitivity, intolerance or idiosyncratic reaction to guaifenesin or any other drug substances with similar activity.

5. Previously enrolled in this study.

6. Participated in another clinical trial or received an investigational product within 30 days prior to drug administration.

7. Unable in the opinion of the Investigator to comply fully with the study requirements.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Reckitt Benckiser LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Reckitt Benckiser LLC
• ClinicalTrials.gov Identifier: NCT03649750
• Other Study ID Numbers: 2013-MUC-01
• First Posted: Aug 28, 2018
• Last Update Posted: Mar 27, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Guaifenesin

Study Results

Participant Flow

Recruitment Details	This was a single-centre study.
Pre-assignment Detail	Total Thirty-six (36) subjects were enrolled in the study among them 36 subjects completed the study.

Arm/Group Title	Cohort 1(Mucinex Fed or Mucinex Fast in Period 1 and Period 2)	Cohort 2(Mucinex Fast or Mucinex Fed in Period 1 and Period 2)
Arm/Group Description	Treatment A (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting. Treatment B (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed. Cohort 1 Period 1 - Treatment A or Treatment B at Sequence AB. Period 2 - Treatment B or Treatment A at Sequence BA. Scheduled Washout of 7 days between drug doses.	Treatment A (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting. Treatment B (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed. Cohort 2 Period 1 - Treatment A or Treatment B at Sequence AB. Period 2 - Treatment B or Treatment A at Sequence BA. Scheduled Washout of 7 days between drug doses.
Period Title: Period 1
STARTED	12	24
COMPLETED	12	24
NOT COMPLETED	0	0
Period Title: Period 1
STARTED	12	24
COMPLETED	12	24
NOT COMPLETED	0	0
Period Title: Period 1
STARTED	12	24
COMPLETED	12	24
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Pharmacokinetic (PK) Dataset
Arm/Group Description	Treatment A (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting. Treatment B (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed. Cohort 1 Period 1 - Treatment A or Treatment B at Sequence AB. Period 2 - Treatment B or Treatment A at Sequence BA. Scheduled Washout of 7 days between drug doses. Cohort 2 Period 1 - Treatment A or Treatment B at Sequence AB. Period 2 - Treatment B or Treatment A at Sequence BA. Scheduled Washout of 7 days between drug doses.
Overall Participants	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37 (9)
Sex: Female, Male (Count of Participants)
Female	17 47.2%
Male	19 52.8%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	170.8 (10.1)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	72.3 (10.4)
Body Mass Index (kg/m²) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m²]	24.7 (2.1)
Age (participants) [Number]
18 - 40 years	21 58.3%
41 - 64 years	15 41.7%
Race (participants) [Number]
Asian	6 16.7%
Black or African American	8 22.2%
White	22 61.1%

Outcome Measures

1. Primary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
Description	Maximum measured analyte concentration over the sampling period.
Time Frame	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 Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment A: Mucinex® 600 mg (Fast)	Treatment B: Mucinex® 600 mg (Fed)
Arm/Group Description	Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.	Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.
Measure Participants	36	36
Mean (Standard Deviation) [ng/ml]	1066.11 (429.91)	1117.31 (424.82)

2. Primary Outcome

Title	Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Plasma Concentration (AUCt) of Guaifenesin
Description	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.
Time Frame	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 Measure Data

Analysis Population Description

Pharmacokinetic Dataset

Arm/Group Title	Treatment A: Mucinex® 600 mg (Fast)	Treatment B: Mucinex® 600 mg (Fed)
Arm/Group Description	Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.	Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.
Measure Participants	36	36
Mean (Standard Deviation) [ng·h/ml]	4052.10 (1495.48)	4084.90 (1380.20)

3. Secondary Outcome

Title	Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin
Description	Time of the maximum measured analyte concentration over the sampling period.
Time Frame	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 Measure Data

Analysis Population Description

Pharmacokinetic Dataset

Arm/Group Title	Treatment A: Mucinex® 600 mg (Fast)	Treatment B: Mucinex® 600 mg (Fed)
Arm/Group Description	Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.	Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.
Measure Participants	36	36
Mean (Standard Deviation) [h]	0.68 (0.32)	3.33 (1.36)

4. Secondary Outcome

Title	Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) of Guaifenesin
Description	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.
Time Frame	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 Measure Data

Analysis Population Description

Pharmacokinetic Dataset

Arm/Group Title	Treatment A: Mucinex® 600 mg (Fast)	Treatment B: Mucinex® 600 mg (Fed)
Arm/Group Description	Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.	Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.
Measure Participants	36	36
Mean (Standard Deviation) [ng·h/ml]	4104.47 (1555.87)	4092.53 (1382.77)

5. Secondary Outcome

Title	Terminal Elimination Rate Constant (Kel) of Guaifenesin
Description	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.
Time Frame	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 Measure Data

Analysis Population Description

Pharmacokinetic Dataset

Arm/Group Title	Treatment A: Mucinex® 600 mg (Fast)	Treatment B: Mucinex® 600 mg (Fed)
Arm/Group Description	Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.	Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.
Measure Participants	36	36
Mean (Standard Deviation) [1/h]	0.3862 (0.1717)	0.6788 (0.1343)

6. Secondary Outcome

Title	Terminal Elimination Half-life (T½) of Guaifenesin
Description	Terminal elimination half-life, calculated from the equation: thalf = In(2)/Kel.
Time Frame	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 Measure Data

Analysis Population Description

Pharmacokinetic Dataset

Arm/Group Title	Treatment A: Mucinex® 600 mg (Fast)	Treatment B: Mucinex® 600 mg (Fed)
Arm/Group Description	Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.	Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.
Measure Participants	36	36
Mean (Standard Deviation) [h]	2.46 (2.62)	1.07 (0.29)

7. Secondary Outcome

Title	Relative Bioavailability (RF) of Guaifenesin
Description	Relative bioavailability for each formulation will be defined as: (AUC0-inf Fasting ÷ AUC0-inf Fed) x (Fed dose ÷ Fasting dose)
Time Frame	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 Measure Data

Analysis Population Description

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

Arm/Group Title	All Study Participants
Arm/Group Description	Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting and fed.
Measure Participants	36
Mean (Standard Deviation) [Percent bioavailability]	1.0081 (0.1655)

8. Secondary Outcome

Title	Number of Adverse Events(AEs) Experienced by Participants
Description	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
Time Frame	Up to period 2 (8.3 days/200 hours)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Dataset Investigational Medicinal Product(IMP)

Arm/Group Title	Treatment A: Mucinex® 600 mg (Fast)	Treatment B: Mucinex® 600 mg (Fed)
Arm/Group Description	Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.	Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.
Measure Participants	36	36
TEAE by severity: Mild	11	14
TEAE by severity: Moderate	0	0
TEAE by severity: Severe	0	0
Relationship to IMP: Unassessable/Unclassifiable	3	5
Relationship to IMP: Conditional /Unclassified	0	0
Relationship to IMP: Unrelated	2	0
Relationship to IMP: Unlikely	0	0
Relationship to IMP: Possible	6	9
Relationship to IMP: Probable	0	0
Relationship to IMP: Certain	0	0

Adverse Events

Time Frame	Up to 8.3 days/ (200 hours)
Arm/Group Title	Treatment A: Mucinex® 600 mg (Fast)		Treatment B: Mucinex® 600 mg (Fed)
Arm/Group Description	Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.		Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.
All Cause Mortality
	Treatment A: Mucinex® 600 mg (Fast)		Treatment B: Mucinex® 600 mg (Fed)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/36 (0%)
Serious Adverse Events
	Treatment A: Mucinex® 600 mg (Fast)		Treatment B: Mucinex® 600 mg (Fed)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/36 (0%)
Other (Not Including Serious) Adverse Events
	Treatment A: Mucinex® 600 mg (Fast)		Treatment B: Mucinex® 600 mg (Fed)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/36 (22.2%)		10/36 (27.8%)
Cardiac disorders
Tachycardia	1/36 (2.8%)	1	0/36 (0%)	0
Gastrointestinal disorders
Abdominal pain lower	1/36 (2.8%)	1	0/36 (0%)	0
General disorders
Vessel puncture site bruise	0/36 (0%)	0	1/36 (2.8%)	1
Vessel puncture site pain	0/36 (0%)	0	1/36 (2.8%)	1
Vessel puncture site swelling	0/36 (0%)	0	1/36 (2.8%)	1
Nervous system disorders
Headache	1/36 (2.8%)	1	2/36 (5.6%)	2
Somnolence	5/36 (13.9%)	5	6/36 (16.7%)	6
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	1/36 (2.8%)	1	0/36 (0%)	0
Vascular disorders
Hypertension	2/36 (5.6%)	2	1/36 (2.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.