Bioequivalence Study Comparing Mucinex Extended-release 600 mg Tablets to Immediate-release Guaifenesin 600 mg in Healthy Volunteers
Condition: Healthy Subjects
Intervention: Mucinex® SE; Vicks Cough Syrup for Chesty Coughs
Intervention description: Single dose of Mucinex® SE extended-release 600 mg bi-layer tablet; Vicks Cough Syrup for Chesty Coughs 15 mL (200 mg guaifenesin q4h) immediate release (IR) syrup
Intervention MeSH terms: Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Determine bioequivalence, safety and tolerability of guaifenesin extended-release 600 mg
      (Mucinex® SE) compared to an immediate-release syrup reference product in normal healthy
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and/or females between the ages of 19 and 55 years, inclusive.

          2. Females of childbearing potential must be using one of the following acceptable birth
             control methods:

               1. Intra-uterine device in place for at least 3 months prior to Day 1 of Period 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 (e.g., oral, depo injection, transdermal patch, or
                  vaginal ring) for at least 3 months prior to Day 1 of Period 1 through 30 days
                  beyond completion of study;

             Abstinence is not an acceptable form of contraception; however, abstinent female
             subjects may be admitted to the study if they agree, and have signed a statement to
             the effect, that upon becoming sexually active, will use a condom with spermicide from
             screening through 30 days beyond completion of the study.

          3. Females of non-childbearing potential should be surgically sterile (bilateral tubal
             ligation with surgery at least 6 months prior to study or hysterectomy and/or
             bilateral oophorectomy at least 3 months prior to Day 1 of Period 1) or postmenopausal
             >2 years prior to Day 1 of Period 1. A follicle stimulating hormone (FSH)
             concentration >40 miU/mL must be obtained and recorded for any postmenopausal females.

          4. Good general health as determined by the Principal Investigator's (PI) review of
             medical history, physical examination, vital sign measurements, electrocardiogram
             (ECG), and clinical laboratory measures.

          5. Body weight between 50 - 100 kg and body mass index (BMI) within 18 - 30 kg/m2.

          6. Non-tobacco users, who have not used nicotine or nicotine-containing products for at
             least 365 days prior to Day 1 of Period 1.

          7. Able to read, understand and sign the informed consent after the nature of the study
             has 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.

         10. Non alcohol or drug abuser - non alcohol abuse is defined as history of less than 4
             drinks daily. A drink 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).

        Exclusion Criteria:

          1. Clinically significant abnormalities detected by medical history, physical
             examination, vial sign measurements, ECG, or clinical laboratory findings (as
             determined by the PI/designee) including a hemoglobin value <12 gm/dL at screening. If
             a subject's hemoglobin drops below 11.0 gm/dL during the study, the subject may be
             dropped from the study at the discretion of the PI.

          2. Any disease or condition, which could impact absorption, distribution, metabolism, or
             elimination of the study drugs (as determined by the PI/designee).

          3. Females who are pregnant or nursing.

          4. History of sensitivity reaction to guaifenesin.

          5. Receipt of an investigational drug within 30 days prior to Day 1 of Period 1.

          6. Abnormal diet (for whatever reason) during the 30 days prior to Day 1 of Period 1.

          7. Donation of blood or significant loss of blood within 56 days or plasma within 14 days
             prior to Day 1 of Period 1.

          8. Known or suspected use of illicit drugs.

          9. 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 of Period 1.

         10. Test positive for Hepatitis B surface antigen, Hepatitis C antibodies, or HIV at
             Screening.