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Study to Evaluate the Pharmacokinetics of Mucinex 600 mg Extended-release Bi-layer Tablet in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03644108
Recruitment Status : Completed
First Posted : August 23, 2018
Results First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC ( Reckitt Benckiser Inc. )

Tracking Information
First Submitted Date  ICMJE August 21, 2018
First Posted Date  ICMJE August 23, 2018
Results First Submitted Date  ICMJE September 18, 2018
Results First Posted Date  ICMJE February 28, 2019
Last Update Posted Date February 28, 2019
Actual Study Start Date  ICMJE June 4, 2009
Actual Primary Completion Date June 15, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
  • Maximum Observed Plasma Concentration (Cmax) of Guaifenesin [ Time Frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2 ]
    Pharmacokinetic Parameters Cmax (Maximum observed drug concentration)
  • Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin [ Time Frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2 ]
    Area under the drug concentration-time curve calculated using linear trapezoidal summation from time zero to time t, where t is the time of the last measurable concentration (Ct).
  • Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin [ Time Frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2 ]
    Area under the drug concentration-time curve from time zero to infinity, AUC(0-inf) = AUC(0-t) + Ct/Kel, where Kel is the terminal elimination rate constant.
  • Time to Maximum Observed Concentration (Tmax) of Guaifenesin [ Time Frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2 ]
    Pharmacokinetic Parameter tmax (Time of the maximum observed drug concentration).
  • Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin [ Time Frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2 ]
    Ratio of AUC(0-t) to AUC(0-inf), referred to as AUCR. [AUCR = AUC(0-t) / AUC(0-inf)]
  • Apparent Terminal Elimination Rate Constant (Kel) of Guaifenesin [ Time Frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2 ]
    Apparent terminal elimination rate constant (Kel) calculated by linear regression of the terminal linear portion of the log concentration-time curve.
  • Apparent Terminal Elimination Half-life (t1/2) of Guaifenesin [ Time Frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2 ]
    Apparent terminal elimination half-life (t1/2) calculated as ln(2)/Kel.
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
  • Maximum Observed Plasma Concentration (Cmax) of Guaifenesin [ Time Frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2 ]
  • Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin [ Time Frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2 ]
  • Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin [ Time Frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2 ]
    AUC(0-inf) = AUC(0-t) + Ct/Kel, where Kel is the terminal elimination rate constant
  • Time to Maximum Observed Concentration (Tmax) of Guaifenesin [ Time Frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2 ]
  • Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin [ Time Frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2 ]
    AUCR = AUC(0-t) / AUC(0-inf)
  • Apparent Terminal Elimination Rate Constant (Kel) of Guaifenesin [ Time Frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2 ]
    Kel is calculated by linear regression of the terminal linear portion of the log concentration-time curve.
  • Apparent Terminal Elimination Half-life (t1/2) of Guaifenesin [ Time Frame: 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2 ]
Change History Complete list of historical versions of study NCT03644108 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to Day 2 ]
Intensity was determined by the Investigator. For symptomatic AEs the following definitions were applied. Mild = AE did not limit usual activities; subject may have experienced slight discomfort. Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort. Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain. Relationship to Investigational Medicinal Products (IMP) Unlikely = Slight, but remote, chance that AE was caused by IMP. Possible = Reasonable suspicion that the AE was caused by IMP. Probable = Most likely that AE was caused by IMP.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
Number of adverse events (AEs) [ Time Frame: Up to Day 2 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Pharmacokinetics of Mucinex 600 mg Extended-release Bi-layer Tablet in Healthy Volunteers
Official Title  ICMJE A Phase I, Open-label, Single-dose, Single-Period Study to Evaluate the Pharmacokinetics of Mucinex® 600 mg Extended-Release Bi-layer Tablet in Normal Healthy Subjects.
Brief Summary Evaluate the Pharmacokinetics of Mucinex® 600 mg Extended-Release Bi-Layer Tablet in Normal Healthy Subjects
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Subjects
Intervention  ICMJE Drug: Mucinex® ER 600 mg
Single dose of Mucinex® 600 mg ER Bi-Layer tablet
Other Name: guaifenesin
Study Arms  ICMJE Experimental: Mucinex® ER 600 mg
Single dose of Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet taken with 240 mL of water after an overnight fast
Intervention: Drug: Mucinex® ER 600 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2018)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 15, 2009
Actual Primary Completion Date June 15, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males and/or females between the ages of 19 and 55 years, inclusive.
  2. Females of childbearing potential must have been using 1 of the following acceptable birth control methods:

    1. Intra-uterine device (IUD) in place for at least 3 months prior to Day 1 through 30 days beyond study completion or first menstrual period.
    2. Barrier method (condom or diaphragm) with spermicide for at least 7 days prior to screening through 30 days beyond study completion or first menstrual period (whichever is longer).
    3. Stable hormonal contraceptive (e.g., PO, depo injection, transdermal patch, or vaginal ring) for at least 3 months prior to Day 1 through 30 days beyond completion of study or first menstrual period.

    Note: Abstinence is not an acceptable form of contraception; however, abstinent female subjects may have been admitted to the study if they agreed, and signed a statement to the effect, that upon becoming sexually active, would use a condom with spermicide from screening through 30 days beyond completion of the study.

  3. Females of non-childbearing potential must have been surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to Day 1 or hysterectomy and/or bilateral oophorectomy at least 3 months prior to Day 1) or postmenopausal >2 years prior to Day 1. A follicle stimulating hormone (FSH) level >40 miU/mL must be obtained and recorded for any postmenopausal females.
  4. Good general health as determined by the PI's review of medical history, physical examination, vital sign measurements, electrocardiogram (ECG), and clinical laboratory measures.
  5. Within 15% of ideal body weight (Table of 'Desirable Weights of Adults' Metropolitan Life Insurance Company, 1983).
  6. Non-tobacco users, who had not used nicotine or nicotine-containing products for at least 365 days prior to Day 1.
  7. Able to read, understand, and sign the informed consent form (ICF), after the nature of the study had been explained.
  8. Negative urine screen for drugs of abuse and alcohol at screening and each check-in.
  9. If female, negative finding on serum pregnancy test at screening and each check-in.

Exclusion Criteria:

  1. Clinically significant abnormalities detected by medical history, physical examination, vital sign measurements, ECG, or clinical laboratory findings (as determined by the PI/designee) including a hemoglobin value <12 g/dL at screening. If a subject's hemoglobin drops below 11.0 g/dL during the study, the subject may be dropped from the study at the discretion of the PI.
  2. Any disease or condition that could impact absorption, distribution, metabolism, or elimination of the study drugs (as determined by the PI/designee).
  3. Alcoholism or medicinal product or drug abuse within the past 2 years or excessive alcohol consumption (more than 10 units per week) (1 unit is 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 could not 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.
  4. Females who were pregnant or nursing.
  5. History of hypersensitivity reaction to guaifenesin.
  6. Receipt of an investigational drug within 30 days prior to Day 1.
  7. Abnormal diet (for whatever reason) during the 30 days prior to Day 1.
  8. Donation of blood or significant loss of blood within 56 days or plasma within 14 days prior to Day 1.
  9. Known or suspected use of illicit drugs.
  10. The use of any medication (with the exception of hormonal contraceptives for women of childbearing potential) for 14 days or 5 half-lives of the drug (whichever is longer) prior to Day 1.
  11. Test positive for Hepatitis B surface antigen, Hepatitis C antibodies, or human immunodeficiency virus (HIV).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03644108
Other Study ID Numbers  ICMJE 2009-GGE-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Reckitt Benckiser LLC ( Reckitt Benckiser Inc. )
Study Sponsor  ICMJE Reckitt Benckiser Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Reckitt Benckiser LLC
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP