Mucinex® ER 600 mg Bi-layer Tablet Versus Guaifenesin Immediate Release (IR) 200 mg q4h

• Sponsor: Reckitt Benckiser Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03642262
• Collaborator: (none)
• Enrollment: 30
• Arms: 2
• Actual Duration (Months): 2.2

Study Details

Study Description

Brief Summary

Demonstrate bioequivalence of guaifenesin in Mucinex® extended release (ER) 600 mg tablet in normal healthy volunteers compared to the immediate release guaifenesin 200 mg tablet reference product marketed

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: 2-Way Crossover2-Way Crossover
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase I, Open-label, Single Dose, Randomized, 2-way Crossover Bioequivalence Study Comparing Mucinex® Extended Release 600 mg Bi-Layer Tablet to a Reference Immediate Release Guaifenesin Tablet (Taken as 200 mg Every 4 Hours [q4h] x 3 Doses) in Normal Healthy Volunteers
• Actual Study Start Date: Jun 2, 2013
• Actual Primary Completion Date: Aug 9, 2013
• Actual Study Completion Date: Aug 9, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A: Mucinex® ER 600 mg Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.	Drug: Mucinex®; Mucinex® 600 mg single dose ER bi-layer tablet; Other Names: guaifenesin
Active Comparator: Treatment B: Guaifenesin 200 mg Guaifenesin 200 mg immediate release (IR) tablet thrice (at 0, 4, and 8 hours) by mouth under fasting condition.	Drug: Mucinex®; Mucinex® 600 mg single dose ER bi-layer tablet; 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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours]

   Maximum measured analyte concentration over the sampling period.

2. Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable 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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours]

   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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours]

   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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours]

   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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours]

   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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours]

   Terminal elimination half-life, calculated from the equation: T½ = 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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours]

   RF is measured by (AUCinf ER / AUCinf IR) x (ER dose / IR 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 Investigational Medicinal Product (IMP)

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 has been obtained (i.e. be informed of the nature of the study and give written consent prior to any study procedure). Able to read, understand, and sign the informed consent, after the nature of the study has 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. Have no significant diseases or clinically relevant medical condition in the opinion of the investigator.

10. Males who participate in this study are 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

• use (or their partner will use, 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 participate in this study are:

• 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. Have no clinically significant findings from a physical examination.

Exclusion Criteria:

Subjects to whom any of the following conditions apply must be excluded:

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 last year.

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 past two years 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

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

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

12. Difficulty fasting or consuming standard meals.

13. Females who are lactating.

14. Does not tolerate venipuncture.

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

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

17. 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 have started taking hormonal contraceptives or have changed their method or brand of hormonal birth control within 3 months prior to drug administration.

2. Have 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 Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Reckitt Benckiser Inc.
• ClinicalTrials.gov Identifier: NCT03642262
• Other Study ID Numbers: 2013-MUC-02
• First Posted: Aug 22, 2018
• Last Update Posted: Jun 17, 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
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Guaifenesin

Study Results

Participant Flow

Recruitment Details	This was a single-centre study conducted in Canada.
Pre-assignment Detail	Total Thirty (30) subjects were enrolled in the study among them 27 subjects completed the study.

Arm/Group Title	Cohort 1 (Mucinex First Then Guaifenesin)	Cohort 2 (Guaifenesin Then Mucinex)
Arm/Group Description	Treatment A : Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition. Treatment B : Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition. 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 administrations.	Treatment A : Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition. Treatment B : Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition. 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 administrations.
Period Title: Period 1
STARTED	12	18
COMPLETED	11	16
NOT COMPLETED	1	2
Period Title: Period 1
STARTED	11	16
COMPLETED	11	16
NOT COMPLETED	0	0
Period Title: Period 1
STARTED	11	16
COMPLETED	11	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Treatment A : Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition. Treatment B : Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition. 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 administrations. 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 administrations.
Overall Participants	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40 (11)
Sex: Female, Male (Count of Participants)
Female	15 50%
Male	15 50%
Age Group (Count of Participants)
18 to 40 years	14 46.7%
41 to 64 years	16 53.3%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	167.4 (9.1)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	67.2 (9.9)
Body Mass Index (kg/m²) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m²]	23.9 (2.2)
Race (participants) [Number]
Asian	5 16.7%
Black or African American	6 20%
White	19 63.3%

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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) Parameter Set Population includes all subjects from the PK dataset with evaluable PK parameters for each treatment period.

Arm/Group Title	Test: RB Mucinex® ER 600 mg	Reference: Guaifenesin 200 mg
Arm/Group Description	Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.	Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
Measure Participants	27	27
Mean (Standard Deviation) [ng/ml]	1076.37 (414.80)	1223.89 (522.04)

2. Primary Outcome

Title	Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable 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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours

Outcome Measure Data

Analysis Population Description

PK Dataset

Arm/Group Title	Test: RB Mucinex® ER 600 mg	Reference: Guaifenesin 200 mg
Arm/Group Description	Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.	Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
Measure Participants	27	27
Mean (Standard Deviation) [ng·h/ml]	4288.30 (1654.57)	4641.48 (2211.99)

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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours

Outcome Measure Data

Analysis Population Description

PK Dataset

Arm/Group Title	Test: RB Mucinex® ER 600 mg	Reference: Guaifenesin 200 mg
Arm/Group Description	Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.	Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
Measure Participants	27	27
Mean (Standard Deviation) [hr]	0.75 (0.33)	1.45 (2.43)

4. Secondary Outcome

Title	Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) of Guaifenesin
Description	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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours

Outcome Measure Data

Analysis Population Description

PK Dataset

Arm/Group Title	Test: RB Mucinex® ER 600 mg	Reference: Guaifenesin 200 mg
Arm/Group Description	Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.	Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
Measure Participants	27	27
Mean (Standard Deviation) [ng·h/ml]	4306.21 (1658.06)	4647.47 (2212.37)

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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours

Outcome Measure Data

Analysis Population Description

PK Dataset

Arm/Group Title	Test: RB Mucinex® ER 600 mg	Reference: Guaifenesin 200 mg
Arm/Group Description	Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.	Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
Measure Participants	27	27
Mean (Standard Deviation) [1/h]	0.4727 (0.1711)	0.7635 (0.1011)

6. Secondary Outcome

Title	Terminal Elimination Half-life (T½) of Guaifenesin
Description	Terminal elimination half-life, calculated from the equation: T½ = 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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours

Outcome Measure Data

Analysis Population Description

PK Dataset

Arm/Group Title	Test: RB Mucinex® ER 600 mg	Reference: Guaifenesin 200 mg
Arm/Group Description	Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.	Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
Measure Participants	27	27
Mean (Standard Deviation) [h]	1.70 (0.75)	0.93 (0.15)

7. Secondary Outcome

Title	Relative Bioavailability (RF) of Guaifenesin
Description	RF is measured by (AUCinf ER / AUCinf IR) x (ER dose / IR 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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours

Outcome Measure Data

Analysis Population Description

Outcome involved analyzing data from both intervention groups (ER and IR) 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	Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition. Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
Measure Participants	27
Mean (Standard Deviation) [ng·h/ml]	0.9542 (0.1770)

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 Investigational Medicinal Product (IMP)
Time Frame	Up to period 2 (8.3 days/200 hours)

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Test: RB Mucinex® ER 600 mg	Reference: Guaifenesin 200 mg
Arm/Group Description	Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.	Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
Measure Participants	28	29
TEAE by severity: Mild	1	9
TEAE by severity: Moderate	0	0
TEAE by severity: Severe	0	0
Relationship to IMP: Unassessable/Unclassifiable	0	3
Relationship to IMP: Conditional /Unclassified	0	0
Relationship to IMP: Unrelated	0	0
Relationship to IMP: Unlikely	0	0
Relationship to IMP: Possible	1	6
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® ER 600 mg		Treatment B: Guaifenesin 200 mg
Arm/Group Description	Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.		Guaifenesin 200 mg immediate release (IR) tablet q4h (total of 3 doses) by mouth under fasting condition.
All Cause Mortality
	Treatment A: Mucinex® ER 600 mg		Treatment B: Guaifenesin 200 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/29 (0%)
Serious Adverse Events
	Treatment A: Mucinex® ER 600 mg		Treatment B: Guaifenesin 200 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Treatment A: Mucinex® ER 600 mg		Treatment B: Guaifenesin 200 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/28 (3.6%)		4/29 (13.8%)
Gastrointestinal disorders
Nausea	0/28 (0%)	0	1/29 (3.4%)	1
Vomiting	0/28 (0%)	0	1/29 (3.4%)	1
General disorders
Asthenia	0/28 (0%)	0	1/29 (3.4%)	1
Catheter site bruise	0/28 (0%)	0	1/29 (3.4%)	1
Catheter site swelling	0/28 (0%)	0	1/29 (3.4%)	1
Nervous system disorders
Headache	1/28 (3.6%)	1	1/29 (3.4%)	1
Somnolence	0/28 (0%)	0	1/29 (3.4%)	1
Skin and subcutaneous tissue disorders
Skin swelling	0/28 (0%)	0	1/29 (3.4%)	1
Vascular disorders
Hypertension	0/28 (0%)	0	1/29 (3.4%)	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.