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Trial record 7 of 483 for:    guaifenesin | Completed Studies

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
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC ( Reckitt Benckiser Inc. )

Brief Summary:
Evaluate the Pharmacokinetics of Mucinex® 600 mg Extended-Release Bi-Layer Tablet in Normal Healthy Subjects

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Mucinex® ER 600 mg Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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.
Actual Study Start Date : June 4, 2009
Actual Primary Completion Date : June 15, 2009
Actual Study Completion Date : June 15, 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Mucinex® ER 600 mg
Single dose of Mucinex® 600 mg ER Bi-Layer tablet
Other Name: guaifenesin




Primary Outcome Measures :
  1. 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 ]
  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 ]
  3. 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

  4. 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 ]
  5. 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)

  6. 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.

  7. 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 ]

Secondary Outcome Measures :
  1. Number of adverse events (AEs) [ Time Frame: Up to Day 2 ]


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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Responsible Party: Reckitt Benckiser Inc.
ClinicalTrials.gov Identifier: NCT03644108     History of Changes
Other Study ID Numbers: 2009-GGE-04
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
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
Phenylpropanolamine
Chlorpheniramine, phenylpropanolamine drug combination
Expectorants
Respiratory System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents