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Mucinex® ER 600 mg Bi-Layer Tablet Fed and Fasted

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ClinicalTrials.gov Identifier: NCT03649750
Recruitment Status : Completed
First Posted : August 28, 2018
Results First Posted : February 22, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC

Tracking Information
First Submitted Date  ICMJE August 20, 2018
First Posted Date  ICMJE August 28, 2018
Results First Submitted Date  ICMJE October 8, 2018
Results First Posted Date  ICMJE February 22, 2019
Last Update Posted Date March 27, 2019
Actual Study Start Date  ICMJE May 29, 2013
Actual Primary Completion Date August 7, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2018)
  • 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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) ]
    Maximum measured analyte concentration over the sampling period.
  • Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Plasma 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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
  • 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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) ]
  • Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Plasma 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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) ]
Change History Complete list of historical versions of study NCT03649750 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • 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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) ]
    Time of the maximum measured analyte concentration over the sampling period.
  • 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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) ]
    The area under the analyte concentration versus time curve from time zero to infinity. AUCinf = AUCt + Cp/Kel, where Cp is the predicted analyte concentration at the time of the last measurable analyte concentration.
  • 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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) ]
    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.
  • 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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) ]
    Terminal elimination half-life, calculated from the equation: thalf = In(2)/Kel.
  • 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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) ]
    Relative bioavailability for each formulation will be defined as: (AUC0-inf Fasting ÷ AUC0-inf Fed) x (Fed dose ÷ Fasting dose)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
  • 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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) ]
    AUCinf = AUCt + Cp/Kel, where Cp is the predicted analyte concentration at the time of the last measurable analyte concentration.
  • 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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) ]
  • 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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) ]
  • 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, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2) ]
    RF is measured as (AUC0-inf Fasting ÷ AUC0-inf Fed) x (Fed dose ÷ Fasting dose)
  • Number of Adverse Events (AEs) [ Time Frame: Up to period 2 (8.3 days/200 hours) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mucinex® ER 600 mg Bi-Layer Tablet Fed and Fasted
Official Title  ICMJE A Phase I, Open-label, Single-dose, Randomized, 2-way Cross-over Study Designed to Examine the Relative Bioavailability of Guaifenesin When a Mucinex Extended Release 600 mg Bi-layer Tablet is Taken Under Fasted Compared to Fed Conditions in Normal Healthy Volunteers
Brief Summary Determine and compare the plasma concentrations of Mucinex® Extended Release (ER) 600 mg bi-layer tablet in normal healthy volunteers in fed and fasting conditions
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Subjects
Intervention  ICMJE Drug: Mucinex®
Mucinex® 600 mg ER bi-layer tablets
Other Name: guaifenesin
Study Arms  ICMJE
  • Experimental: Treatment A: Mucinex® 600 mg (fast)
    Mucinex® 600 mg ER bi-layer tablet by mouth after 10 hours fasting and subject will fast at least 4 hours post-dose
    Intervention: Drug: Mucinex®
  • Experimental: Treatment B: Mucinex® 600 mg (fed)
    Mucinex® 600 mg ER bi-layer tablet by mouth in fed condition. After an overnight fast of at least 10 hours, subjects will consume a high fat, high calorie breakfast starting 30 minutes prior to drug administration
    Intervention: Drug: Mucinex®
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 24, 2018)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 7, 2013
Actual Primary Completion Date August 7, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Informed consent was obtained (i.e. be informed of the nature of the study and given written consent prior to any study procedure). Able to read, understand, and sign the informed consent, after the nature of the study had 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. Had no significant diseases or clinically relevant medical condition in the opinion of the Investigator
  10. Males who participated in this study were 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
    • used (or their partner used, 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 participated in this study were:

    • 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. Had no clinically significant findings from a physical examination.

Exclusion Criteria:

  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 year preceding the study.
  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 two years preceding the study 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 were lactating.
  14. Did 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 had started taking hormonal contraceptives or had changed their method or brand of hormonal birth control within 3 months prior to drug administration.
  19. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 NCT03649750
Other Study ID Numbers  ICMJE 2013-MUC-01
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
Study Sponsor  ICMJE Reckitt Benckiser LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Reckitt Benckiser LLC
Verification Date March 2019

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