Bioequivalence Study Comparing Mucinex Extended-release 600 mg Tablets to Immediate-release Guaifenesin 600 mg in Healthy Volunteers

Inclusion criteria

• Males and/or females between the ages of 19 and 55 years, inclusive.
• Females of childbearing potential must be using one of the following acceptable birth control methods:

• Intra-uterine device in place for at least 3 months prior to Day 1 of Period 1 through 30 days beyond study completion;
• Barrier method (condom or diaphragm) with spermicide for at least 7 days prior to screening through 30 days beyond study completion;
• 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.

• 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.
• 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.
• Body weight between 50 - 100 kg and body mass index (BMI) within 18 - 30 kg/m2.
• Non-tobacco users, who have not used nicotine or nicotine-containing products for at least 365 days prior to Day 1 of Period 1.
• Able to read, understand and sign the informed consent after the nature of the study has been explained.
• Negative urine screen for drugs of abuse and alcohol at screening and each check in.
• If female, negative finding on serum pregnancy test at screening and each check-in.
• 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

• 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.
• Any disease or condition, which could impact absorption, distribution, metabolism, or elimination of the study drugs (as determined by the PI/designee).
• Females who are pregnant or nursing.
• History of sensitivity reaction to guaifenesin.
• Receipt of an investigational drug within 30 days prior to Day 1 of Period 1.
• Abnormal diet (for whatever reason) during the 30 days prior to Day 1 of Period 1.
• Donation of blood or significant loss of blood within 56 days or plasma within 14 days prior to Day 1 of Period 1.
• Known or suspected use of illicit drugs.
• 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.
• Test positive for Hepatitis B surface antigen, Hepatitis C antibodies, or HIV at Screening.