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About
Evaluate the pharmacokinetics (PK), Safety and tolerability of guaifenesin (Mucinex®) in an immediate-release formulation when a single dose is administered in adolescents and in adults when compared to Children.
Enrollment
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Volunteers
Inclusion criteria
Males and females ≥ 12 and < 18 years of age or ≥ 18 and < 55 years of age.
All females who were of childbearing potential had to be 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 agreed, and had signed a statement to the effect, that upon becoming sexually active, would use a condom with spermicide from that time through 30 days beyond completion of the study (Day 1 of Period 2).
Females ≥ 18 years of age of non-childbearing potential must have been surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to Day 1 of Period 1 or hysterectomy and/or bilateral oophorectomy at least 3 months prior to Day 1 of Period 1) or post-menopausal ≥ 2 years prior to Day 1 of Period 1. A follicle stimulating hormone (FSH) level > 40 miU/mL must have been obtained and in the record for any post-menopausal female experiencing their last menses < 2 years prior to Day 1 of Period 1.
Negative urine pregnancy test at Screening and each Check-in for all female subjects.
Good general health as determined by the PI's review of medical history, physical examination, vital sign measurements (after 2 minutes resting in the seated position), and clinical laboratory measures.
For subjects ≥ 18 and < 55 years of age, body mass index (BMI) of 19 to 29 kg/m2, inclusive. (BMI = weight (kg)/[height (m)]2).
Subjects ≥ 12 and < 18 years of age had to be > 5th percentile and less than the 95th percentile for weight and BMI of ≥ 18 to ≤ 28 kg/m2 based on age and gender.
Non-tobacco users, who had not used nicotine or nicotine-containing products for at least 1 year prior to Day 1 of Period 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 each Check-in.
Likely to be compliant and complete the study, and if < 18 years of age had parent(s) or legally authorized representative(s) likely to be compliant with study requirements, according to the PI.
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 IRB-approved informed consent/assent form for subjects to participate in the study. Additionally, for subjects < 18 years of age, a parent(s) or legally authorized representative(s), had to read, sign, and date an IRB-approved informed consent/assent form for subjects < 18 years of age to participate in the study.
Subjects < 18 years of age must have met the following at-risk requirements:
Exclusion criteria
Subject Exclusion Criteria at Check-In
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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