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Characterize and assess PK of guaifenesin in Mucinex® 1200 mg ER Bi-Layer Tablet
Full description
A Phase I, Open-Label, Single-Dose, Single Period Study to Evaluate the Pharmacokinetics of Mucinex® 1200 mg Extended-Release Bi-Layer Tablet in Normal Healthy Subjects
Enrollment
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Inclusion criteria
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:
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.
Negative serum pregnancy test at Screening and at Check-in for all female subjects.
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.
Body mass index (BMI) of 19 to 29 kg/m2, inclusive. (BMI = weight (kg)/[height (m2)]).
Non-tobacco users, who had not used nicotine or nicotine-containing products for at least 6 months prior to Day 1.
Negative finding on tests for Hepatitis B surface antigen (HBsAG), Hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV).
Negative urine screen for drugs of abuse and alcohol at Screening and at Check-in.
Likely to be compliant with study requirements and complete the study, as determined by the Investigator.
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
Primary purpose
Allocation
Interventional model
Masking
24 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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