Healthy SubjectsPhase 1NCT03633448

Study to Evaluate the Pharmacokinetics of Guaifenesin in Adults and Adolescents

A Phase 1 study testing Children's Mucinex® Grape Flavor in people with Healthy Subjects, run by Reckitt Benckiser LLC.

Completed

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

Trial summary

Evaluate the pharmacokinetics (PK), Safety and tolerability of guaifenesin (Mucinex®) in an immediate-release formulation when a single dose is administered in adolescents and in adults when compared to Children. Read more about this study

Who is it for?: Ages 12 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: Children's Mucinex® Grape Flavor
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: 18 Jun 2011to 1 Jul 2011
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 12 to 55 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Males and females ≥ 12 and < 18 years of age or ≥ 18 and < 55 years of age.
All females who were of childbearing potential had to be using one of the following acceptable birth control methods for the time periods specified:
Intrauterine device (IUD) in place for at least 3 months prior to Day 1 of Period 1 through 30 days beyond study completion (Day 1 of Period 2).
Barrier method (condom or diaphragm) with spermicide for at least 7 days prior to screening through 30 days beyond study completion (Day 1 of Period 2)
Stable hormonal contraceptive (oral, depo injection, transdermal patch, or vaginal ring) for at least 3 months prior to Day 1 of Period 1 through 30 days beyond completion of study (Day 1 of Period 2).
Note: Abstinence (sexually inactive) was not an acceptable form of contraception; however, abstinent female subjects could have been admitted to the study if they agreed, and had signed a statement to the effect, that upon becoming sexually active, would use a condom with spermicide from that time through 30 days beyond completion of the study (Day 1 of Period 2).

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Females ≥ 18 years of age of non-childbearing potential must have been surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to Day 1 of Period 1 or hysterectomy and/or bilateral oophorectomy at least 3 months prior to Day 1 of Period 1) or post-menopausal ≥ 2 years prior to Day 1 of Period 1. A follicle stimulating hormone (FSH) level > 40 miU/mL must have been obtained and in the record for any post-menopausal female experiencing their last menses < 2 years prior to Day 1 of Period 1.
Negative urine pregnancy test at Screening and each Check-in for all female subjects.
Good general health as determined by the PI's review of medical history, physical examination, vital sign measurements (after 2 minutes resting in the seated position), and clinical laboratory measures.
For subjects ≥ 18 and < 55 years of age, body mass index (BMI) of 19 to 29 kg/m2, inclusive. (BMI = weight (kg)/[height (m)]2).
Subjects ≥ 12 and < 18 years of age had to be > 5th percentile and less than the 95th percentile for weight and BMI of ≥ 18 to ≤ 28 kg/m2 based on age and gender.
Non-tobacco users, who had not used nicotine or nicotine-containing products for at least 1 year prior to Day 1 of Period 1.
Negative finding on tests for hepatitis B surface antigen (HBsAG), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV).
Negative urine screen for drugs of abuse and alcohol at Screening and each Check-in.
Likely to be compliant and complete the study, and if < 18 years of age had parent(s) or legally authorized representative(s) likely to be compliant with study requirements, according to the PI.
Able to read, understand, and sign the informed consent, after the nature of the study had been explained, and had read, signed, and dated an IRB-approved informed consent/assent form for subjects to participate in the study. Additionally, for subjects < 18 years of age, a parent(s) or legally authorized representative(s), had to read, sign, and date an IRB-approved informed consent/assent form for subjects < 18 years of age to participate in the study.
Subjects < 18 years of age must have met the following at-risk requirements:
Frequency - a history of frequent upper respiratory infections (URIs) defined as > 4 infections per year for adolescents aged ≥ 12 to < 18 yrs, AND;
Exposure - Another family member in the home who was ill with URI/common cold or a child in the family who was attending preschool or school with ≥ 6 children in the group, AND;
Crowding - Greater than (>) 4 persons living in the home or > 3 persons sleeping in one bedroom.

Who cannot join

Clinically significant abnormalities detected by medical history, physical examination, vital sign measurements, ECG findings, or clinical laboratory findings (as determined by the PI), including a hemoglobin value < 12 gm/dL at Screening.
Females who were pregnant or nursing.
History of hypersensitivity reaction to guaifenesin or to EMLA® cream (eutectic mixture of local anesthetic) or its components (lidocaine + prilocaine as local anesthetic).
Receipt of an investigational drug within 30 days prior to Day 1 of Period 1.
Abnormal diet (for whatever reason) during the 30 days prior to Day 1 of Period 1.
Donation of blood or significant loss of blood within 56 days prior to Day 1 of Period 1.

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Donation of plasma within 14 days prior to Day 1 of Period 1.
Known or suspected use of illicit drugs (i.e., opiates, barbiturates, marijuana, et. al.).
The use of any medication on a chronic basis, with the exception of hormonal contraceptives for women of child-bearing potential. An appropriate drug free period for prescription or OTC drugs should have been provided to wash out any especially long half-life drugs.
Alcoholism or medicinal product or drug abuse within the past two years or excessive alcohol consumption (more than 10 units per week) (one unit was defined as 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of spirits (i.e., "hard" liquor such as gin, whiskey, or vodka, et. al.). The subject was not to experience tolerance, withdrawal, compulsive use, or substance related problems such as medical complications, disruption in social and family relationships, vocational or financial difficulties, or legal problems.
Consumption of grapefruit, pummelo, Seville orange or grapefruit juice within 14 days prior to dosing with study medication. Subjects had to be willing to abstain from consuming any of these products during the study.
Related to persons involved directly or indirectly with the conduct of this study (i.e., PI, Sub-Investigators, Study Coordinators, other study personnel, employees of Reckitt Benckiser, and the families of each).
Subject Exclusion Criteria at Check-In
Any significant change from Screening in medical history, medication history, alcohol consumption, or tobacco/nicotine use, in the opinion of the PI.
Reports any known enzyme-inducer, enzyme-inhibitor, or reported chronic exposure to enzyme-inducers such as paint solvents or pesticides since Screening, unless approved by Reckitt Benckiser.
Reports any other prescription or OTC drug or herbal remedy since Screening (except for low-dose contraceptives, multivitamins, and/or fluoride supplements) unless allowed by Reckitt Benckiser.
If female, a positive urine pregnancy test.
Had an acute illness since Screening, unless allowed by Reckitt Benckiser.

About this study

Official title: An Open-label, Single-dose, Randomized, Two-way Crossover Study to Evaluate the Pharmacokinetics of Guaifenesin in Adults and Adolescents at Immediate-release Doses of 200 mg and 400 mg.

Conditions: Healthy Subjects
Being tested: Children's Mucinex® Grape Flavor

What participants receive

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

Children's Mucinex® Grape FlavorDrug
1 x 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation
Children's Mucinex® Grape FlavorDrug
1 x 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation

Study groups in NCT03633448
Study group	Role	What they receive
Mucinex® 1 x 200 mg (10 mL)	Experimental	1 x 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation Receives: Drug: Children's Mucinex® Grape Flavor
Mucinex® 1 x 400 mg (20 mL)	Experimental	1 x 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation Receives: Drug: Children's Mucinex® Grape Flavor

What is being measured

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

Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin
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.
Measured: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin
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.
Measured: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Percent of AUC 0-inf Extrapolated (AUC%Extrapolated)
Percent of AUC 0-inf extrapolated, calculated as (1 - AUC 0-t / AUC 0-inf) x 100.
Measured: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
Pharmacokinetic Parameter (Cmax) Maximum observed plasma concentration.
Measured: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Time to Maximum Observed Concentration (Tmax) of Guaifenesin
Pharmacokinetic Parameter (Tmax) Time of the maximum observed plasma concentration.
Measured: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Apparent First-order Terminal Elimination Half-life (t½)
Apparent first-order terminal elimination half-life, calculated as ln(2)/kel.
Measured: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Apparent First-order Terminal Elimination Rate Constant (Kel)
Apparent first-order terminal elimination rate constant calculated from a semilog 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., three or more non-zero plasma concentrations) in the terminal log-linear phase.
Measured: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours

Secondary outcomes (1)

Number of Adverse Events (AEs) of 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; 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.
Measured: Upto Day 1

Timeline

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

18 Jun 20111 Jul 2011

First posted16 Aug 2018
Study start18 Jun 2011
Primary completion1 Jul 2011
Study completion1 Jul 2011

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
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03633448
Sponsor's protocol ID: 2011-GGE-06
Status last verified: Mar 2019
First submitted: 14 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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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: An Open-label, Single-dose, Randomized, Two-way Crossover Study to Evaluate the Pharmacokinetics of Guaifenesin in Adults and Adolescents at Immediate-release Doses of 200 mg and 400 mg.
ClinicalTrials.gov ID: NCT03633448
Acronym / sponsor ID: 2011-GGE-06
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Reckitt Benckiser LLCIndustry (pharma, biotech, devices)
Study start: 18 Jun 2011 (actual)
Primary completion: 1 Jul 2011 (actual)
Study completion: 1 Jul 2011 (actual)
First posted: 16 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

Arm	Type	Receives
Mucinex® 1 x 200 mg (10 mL)	Experimental	Drug: Children's Mucinex® Grape Flavor1 x 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation
Mucinex® 1 x 400 mg (20 mL)	Experimental	Drug: Children's Mucinex® Grape Flavor1 x 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation

Who may qualify

Ages: 12 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (20 listed)

Males and females ≥ 12 and < 18 years of age or ≥ 18 and < 55 years of age.
All females who were of childbearing potential had to be using one of the following acceptable birth control methods for the time periods specified:
Note: Abstinence (sexually inactive) was not an acceptable form of contraception; however, abstinent female subjects could have been admitted to the study if they agreed, and had signed a statement to the effect, that upon becoming sexually active, would use a condom with spermicide from that time through 30 days beyond completion of the study (Day 1 of Period 2).
Females ≥ 18 years of age of non-childbearing potential must have been surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to Day 1 of Period 1 or hysterectomy and/or bilateral oophorectomy at least 3 months prior to Day 1 of Period 1) or post-menopausal ≥ 2 years prior to Day 1 of Period 1. A follicle stimulating hormone (FSH) level > 40 miU/mL must have been obtained and in the record for any post-menopausal female experiencing their last menses < 2 years prior to Day 1 of Period 1.
Negative urine pregnancy test at Screening and each Check-in for all female subjects.

Key exclusion criteria (18 listed)

Clinically significant abnormalities detected by medical history, physical examination, vital sign measurements, ECG findings, or clinical laboratory findings (as determined by the PI), including a hemoglobin value < 12 gm/dL at Screening.
Females who were pregnant or nursing.
History of hypersensitivity reaction to guaifenesin or to EMLA® cream (eutectic mixture of local anesthetic) or its components (lidocaine + prilocaine as local anesthetic).
Receipt of an investigational drug within 30 days prior to Day 1 of Period 1.
Abnormal diet (for whatever reason) during the 30 days prior to Day 1 of Period 1.

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
Children's Mucinex® Grape Flavor1 x 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation	Drug	Mucinex® 1 x 200 mg (10 mL)
Children's Mucinex® Grape Flavor1 x 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation	Drug	Mucinex® 1 x 400 mg (20 mL)

Primary outcome

Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
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.
Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
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.
Percent of AUC 0-inf Extrapolated (AUC%Extrapolated)
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Percent of AUC 0-inf extrapolated, calculated as (1 - AUC 0-t / AUC 0-inf) x 100.
Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Pharmacokinetic Parameter (Cmax) Maximum observed plasma concentration.
Time to Maximum Observed Concentration (Tmax) of Guaifenesin
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Pharmacokinetic Parameter (Tmax) Time of the maximum observed plasma concentration.
Apparent First-order Terminal Elimination Half-life (t½)
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Apparent first-order terminal elimination half-life, calculated as ln(2)/kel.
Apparent First-order Terminal Elimination Rate Constant (Kel)
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Apparent first-order terminal elimination rate constant calculated from a semilog 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., three or more non-zero plasma concentrations) in the terminal log-linear phase.

1 secondary outcome

Number of Adverse Events (AEs) of Participants
Time frame: Upto Day 1

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
200mg Dose of Guaifenesin, Then 400mg Dose of Guaifenesin	12	12
400mg Dose of Guaifenesin, Then 200mg Dose of Guaifenesin	12	12

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

Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Treatment A (Adolescents) n = 12	Treatment A (Adults) n = 12	Treatment B (Adolescents) n = 12	Treatment B (Adults) n = 12
Value	1990 (929)	1700 (742)	4390 (1590)	3910 (1500)

Population analysed: Pharmacokinetic (PK) Data Sets included only those subjects who swallowed the whole dose (did not spit it out), did not vomit within one hour of dosing, and who had a sufficient number of plasma concentrations to estimate the primary PK parameters for at least one dose level.

Primary outcome: Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin

Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Treatment A (Adolescents) n = 12	Treatment A (Adults) n = 12	Treatment B (Adolescents) n = 12	Treatment B (Adults) n = 12
Value	2090 (916)	1710 (744)	4400 (1600)	3930 (1500)

Population analysed: PK Data Sets

Primary outcome: Percent of AUC 0-inf Extrapolated (AUC%Extrapolated)

Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours. Mean (Standard Deviation). Unit: Percentage

Measure	Treatment A (Adolescents) n = 12	Treatment A (Adults) n = 12	Treatment B (Adolescents) n = 12	Treatment B (Adults) n = 12
Value	0.469 (0.426)	0.736 (0.775)	0.476 (0.431)	0.386 (0.134)

Population analysed: PK Data Sets

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

Time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours. Mean (Standard Deviation). Unit: ng/mL

Measure	Treatment A (Adolescents) n = 12	Treatment A (Adults) n = 12	Treatment B (Adolescents) n = 12	Treatment B (Adults) n = 12
Value	1360 (968)	887 (419)	2690 (1220)	1950 (739)

Population analysed: PK Data Sets

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to Day 14. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A (Adolescents)	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Treatment A (Adults)	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Treatment B (Adolescents)	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Treatment B (Adults)	0 of 12 (0%)	1 of 12 (8.3%)	1 of 12

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 Children's Mucinex® Grape Flavor in people with Healthy Subjects, run by Reckitt Benckiser LLC.

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 20 inclusion and 18 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?

Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin (time frame: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours). The study lists 7 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 NCT03633448.

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.