Healthy SubjectsPhase 1NCT03642262

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

A Phase 1 study testing Mucinex® in people with Healthy Subjects, run by Reckitt Benckiser Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: Mucinex®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: 2 Jun 2013to 9 Aug 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.
Age: 18 to 55 years of age, inclusive.
Sex: Male or female.
Status: Healthy subjects.
BMI: ≥18.0 and ≤28.0 kg/m2.
No clinically significant findings in vital signs measurements at screening.

Show all 17Show fewer

No clinically significant abnormal laboratory values at screening.
No clinically significant findings from a 12-lead electrocardiogram (ECG) at screening.
Have no significant diseases or clinically relevant medical condition in the opinion of the investigator.
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.
Have no clinically significant findings from a physical examination.

Who cannot join

Subjects to whom any of the following conditions apply must be excluded:
Employee of Pharma Medica Research Inc. (PMRI) or Reckitt Benckiser.
Partner or first-degree relative of any Investigator at PMRI.
Known history or presence of any clinically significant medical condition.
Known or suspected carcinoma.
Presence of hepatic or renal dysfunction.

Show all 27Show fewer

Presence of clinically significant gastrointestinal disease or history of malabsorption within the last year.
Known history or presence of galactose or fructose intolerance, sucrase-isomaltase insufficiency, Lapp lactase insufficiency, galactosemia, or glucose-galactose malabsorption syndrome.
Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
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
Positive test result for serum Human Chorionic Gonadotropin (hCG) consistent with pregnancy (females only), HIV, Hepatitis B surface antigen or Hepatitis C antibody.
Positive test result for urine drugs of abuse (cannabinoids, opiates, amphetamines, cocaine, phencyclidine, tricyclic antidepressants, barbiturates, methadone and benzodiazepines) or urine cotinine.
Difficulty fasting or consuming standard meals.
Females who are lactating.
Does not tolerate venipuncture.
Use of tobacco or nicotine-containing products within 12 months prior to drug administration.
On a special diet within 30 days prior to drug administration (e.g., liquid, protein, raw, food diet).
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.
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.
Have had a tattoo or body piercing within 30 days prior to drug administration.
Use of drugs of the monoamine oxidase inhibitor (MAOI) class within 30 days prior to drug administration.
Known history or presence of hypersensitivity, intolerance or idiosyncratic reaction to guaifenesin or any other drug substances with similar activity.
Previously enrolled in this study.
Participated in another clinical trial or received an investigational product within 30 days prior to drug administration.
Unable in the opinion of the Investigator to comply fully with the study requirements.

About this study

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

Conditions: Healthy Subjects
Being tested: Mucinex®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mucinex®Drug
Also called guaifenesin
Mucinex® 600 mg single dose ER bi-layer tablet

Study groups in NCT03642262
Study group	Role	What they receive
Treatment A: Mucinex® ER 600 mg	Experimental	Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition. Receives: Drug: Mucinex®
Treatment B: Guaifenesin 200 mg	Active comparator	Guaifenesin 200 mg immediate release (IR) tablet thrice (at 0, 4, and 8 hours) by mouth under fasting condition. Receives: Drug: Mucinex®

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
Maximum measured analyte concentration over the sampling period.
Measured: 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
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Guaifenesin
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.
Measured: 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

Secondary outcomes (6)

Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin
Time of the maximum measured analyte concentration over the sampling period.
Measured: 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
Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) of Guaifenesin
AUCinf = AUCt + Cp/Kel, where Cp is the predicted analyte concentration at the time of the last measurable analyte concentration.
Measured: 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 Rate Constant (Kel) of Guaifenesin
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
Measured: 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 (T½) of Guaifenesin
Terminal elimination half-life, calculated from the equation: T½ = In(2)/Kel.
Measured: 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
Relative Bioavailability (RF) of Guaifenesin
RF is measured by (AUCinf ER / AUCinf IR) x (ER dose / IR dose)
Measured: 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
Number of Adverse Events(AEs) Experienced by Participants
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)
Measured: Up to period 2 (8.3 days/200 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jun 20139 Aug 2013

First posted22 Aug 2018
Study start2 Jun 2013
Primary completion9 Aug 2013
Study completion9 Aug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy SubjectsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: 2-Way Crossover
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03642262
Sponsor's protocol ID: 2013-MUC-02
Status last verified: Mar 2019
First submitted: 20 Aug 2018
Last updated: 17 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Healthy Subjects trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03642262
Acronym / sponsor ID: 2013-MUC-02
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Reckitt Benckiser Inc.Industry (pharma, biotech, devices)
Study start: 2 Jun 2013 (actual)
Primary completion: 9 Aug 2013 (actual)
Study completion: 9 Aug 2013 (actual)
First posted: 22 Aug 2018 (actual)
Results: Posted 17 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: 2-Way Crossover

Arm	Type	Receives
Treatment A: Mucinex® ER 600 mg	Experimental	Drug: Mucinex®Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.
Treatment B: Guaifenesin 200 mg	Active comparator	Drug: Mucinex®Guaifenesin 200 mg immediate release (IR) tablet thrice (at 0, 4, and 8 hours) by mouth under fasting condition.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (17 listed)

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.
Age: 18 to 55 years of age, inclusive.
Sex: Male or female.
Status: Healthy subjects.
BMI: ≥18.0 and ≤28.0 kg/m2.

Key exclusion criteria (27 listed)

Employee of Pharma Medica Research Inc. (PMRI) or Reckitt Benckiser.
Partner or first-degree relative of any Investigator at PMRI.
Known history or presence of any clinically significant medical condition.
Known or suspected carcinoma.
Presence of hepatic or renal dysfunction.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mucinex®Also: guaifenesinMucinex® 600 mg single dose ER bi-layer tablet	Drug	Treatment A: Mucinex® ER 600 mg, Treatment B: Guaifenesin 200 mg

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
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
Maximum measured analyte concentration over the sampling period.
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Guaifenesin
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
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.

6 secondary outcomes

Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin
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
Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) of Guaifenesin
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
Terminal Elimination Rate Constant (Kel) of Guaifenesin
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
Terminal Elimination Half-life (T½) of Guaifenesin
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
Relative Bioavailability (RF) of Guaifenesin
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
Number of Adverse Events(AEs) Experienced by Participants
Time frame: Up to period 2 (8.3 days/200 hours)

Results and safety

Results posted to the registry on 17 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 (Mucinex First Then Guaifenesin)	12	11
Cohort 2 (Guaifenesin Then Mucinex)	18	16

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Guaifenesin

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. Mean (Standard Deviation). Unit: ng/ml

Measure	Test: RB Mucinex® ER 600 mg n = 27	Reference: Guaifenesin 200 mg n = 27
Value	1076.37 (414.80)	1223.89 (522.04)

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

Primary outcome: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Guaifenesin

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. Mean (Standard Deviation). Unit: ng·h/ml

Measure	Test: RB Mucinex® ER 600 mg n = 27	Reference: Guaifenesin 200 mg n = 27
Value	4288.30 (1654.57)	4641.48 (2211.99)

Population analysed: PK Dataset

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 8.3 days (200 hours). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A: Mucinex® ER 600 mg	0 of 28 (0%)	1 of 28 (3.6%)	0 of 28
Treatment B: Guaifenesin 200 mg	0 of 29 (0%)	4 of 29 (13.8%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mucinex® in people with Healthy Subjects, run by Reckitt Benckiser Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) of Guaifenesin (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03642262.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019.