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

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ClinicalTrials.gov Identifier: NCT03642262
Recruitment Status : Completed
First Posted : August 22, 2018
Results First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC ( Reckitt Benckiser Inc. )

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 2-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 : June 2, 2013
Actual Primary Completion Date : August 9, 2013
Actual Study Completion Date : August 9, 2013

Resource links provided by the National Library of Medicine


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 Name: 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 Name: guaifenesin




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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, calculated from the equation: T½ = In(2)/Kel.

  5. 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 ]
    RF is measured by (AUCinf ER / AUCinf IR) x (ER dose / IR dose)

  6. Number of Adverse Events(AEs) Experienced by Participants [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  11. 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.
  18. 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.
  19. Have had a tattoo or body piercing within 30 days prior to drug administration.
  20. Use of drugs of the monoamine oxidase inhibitor (MAOI) class within 30 days prior to drug administration.
  21. Known history or presence of hypersensitivity, intolerance or idiosyncratic reaction to guaifenesin or any other drug substances with similar activity.
  22. Previously enrolled in this study.
  23. Participated in another clinical trial or received an investigational product within 30 days prior to drug administration.
  24. Unable in the opinion of the Investigator to comply fully with the study requirements.

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Responsible Party: Reckitt Benckiser Inc.
ClinicalTrials.gov Identifier: NCT03642262     History of Changes
Other Study ID Numbers: 2013-MUC-02
First Posted: August 22, 2018    Key Record Dates
Results First Posted: June 17, 2019
Last Update Posted: June 17, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Phenylpropanolamine
Guaifenesin
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