Study to Evaluate the Pharmacokinetics of Mucinex® 1200 mg Extended-Release Tablet
Condition: Healthy Subjects
Intervention: Mucinex®
Intervention description: Mucinex® 1200 mg ER Bi-Layer tablet
Intervention MeSH terms: Guaifenesin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Characterize and assess PK of guaifenesin in Mucinex® 1200 mg ER Bi-Layer Tablet
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females ≥19 to 55 years of age inclusive.

             All females who were of childbearing potential must have been using one of the
             following acceptable birth control methods for the time periods specified:

               1. Intrauterine device (IUD) in place for at least 3 months prior to Day 1 through
                  30 days beyond study completion.

               2. Barrier method (condom or diaphragm) with spermicide for at least 7 days prior to
                  screening through 30 days beyond study completion.

               3. Stable hormonal contraceptive (oral, depo injection, transdermal patch, or
                  vaginal ring) for at least 3 months prior to Day 1 through 30 days beyond
                  completion of study.

             Note: Abstinence (sexually inactive) was not an acceptable form of contraception;
             however, abstinent female subjects could have been admitted to the study if they had
             reported being abstinent at least 14 days prior to screening and they agreed, and
             signed an "Abstinence Statement" to the effect, that upon becoming sexually active,
             they would use a condom with spermicide from that time through 30 days beyond
             completion of the study.

             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 post-menopausal ≥2 years
             prior to Day 1). A follicle stimulating hormone level (FSH) >40 mIU/mL must have been
             obtained and in the record for any post-menopausal female.

          2. Negative serum pregnancy test at Screening and at Check-in for all female subjects.

          3. Good general health as determined by the PI's review of medical history, physical
             examination, 12-lead electrocardiogram (ECG), vital sign measurements (after 2 minutes
             resting in the seated position), and clinical laboratory measures.

          4. Body mass index (BMI) of 19 to 29 kg/m2, inclusive. (BMI = weight (kg)/[height (m2)]).

          5. Non-tobacco users, who had not used nicotine or nicotine-containing products for at
             least 6 months prior to Day 1.

          6. Negative finding on tests for Hepatitis B surface antigen (HBsAG), Hepatitis C virus
             (HCV) antibodies, human immunodeficiency virus (HIV).

          7. Negative urine screen for drugs of abuse and alcohol at Screening and at Check-in.

          8. Likely to be compliant with study requirements and complete the study, as determined
             by the Investigator.

          9. 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 Institutional Review Board
             (IRB)-approved informed consent form for subjects to participate in the study.

        Exclusion Criteria:

          1. Clinically significant abnormalities detected by medical history, physical
             examination, vital sign measurements, ECG findings, or clinical laboratory findings
             (as determined by the PI). If the subject's hemoglobin dropped below 11.0 gm/dL during
             the study, the subject may have been dropped from the study at the discretion of the
             PI/designee.

          2. Any disease or condition, which could impact absorption, distribution, metabolism, or
             elimination of the study drug (as determined by the PI/designee).

          3. Females who were pregnant or nursing.

          4. History of hypersensitivity reaction to guaifenesin.

          5. Receipt of an investigational drug within 30 days prior to Day 1.

          6. Abnormal diet (for whatever reason) during the 30 days prior to Day 1.

          7. Donation of blood or significant loss of blood within 56 days prior to Day 1.

          8. Donation of plasma within 14 days prior to Day 1.

          9. Known or suspected use of illicit drugs (i.e., opiates, barbiturates, marijuana, et.
             al.).

         10. The use of any medication, prescription or over-the-counter (OTC) (including herbal
             supplements) within the 14 days or 5 half-lives of the drug (whichever was longer)
             prior to Day 1 (with the exception of hormonal contraceptives for women of
             child-bearing potential).

         11. Alcoholism or medicinal product or drug abuse within the past two years or excessive
             alcohol consumption (more than 10 units per week) [one 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 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.

         12. Consumption of grapefruit, pummelo, Seville orange, or grapefruit juice within 14 days
             prior to dosing on Day 1 through study completion.

         13. Consumption of alcohol within the 48 hours prior to dosing on Day 1.

         14. Persons involved directly with the conduct of this study (i.e., Investigator,
             Sub-Investigators, Study Coordinators, etc.) or employees of Reckitt Benckiser and
             their families.