Mucinex® ER 600 mg Bi-Layer Tablet Fed and Fasted

NCT03649750 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 2013-MUC-01
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

Determine and compare the plasma concentrations of Mucinex® Extended Release (ER) 600 mg bi-layer tablet in normal healthy volunteers in fed and fasting conditions

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Plasma Concentration (Cmax) of Guaifenesin

  Maximum measured analyte concentration over the sampling period.

  0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)

• Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Plasma Concentration (AUCt) of Guaifenesin

  The area under the analyte concentration versus time curve, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear trapezoidal method.

  0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)

Secondary Outcomes (6)

• Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin

  0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)

• Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) of Guaifenesin

  0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)

• Terminal Elimination Rate Constant (Kel) of Guaifenesin

  0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)

• Terminal Elimination Half-life (T½) of Guaifenesin

  0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)

• Relative Bioavailability (RF) of Guaifenesin

  0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)

Study Arms (2)

Treatment A: Mucinex® 600 mg (fast)

EXPERIMENTAL

Mucinex® 600 mg ER bi-layer tablet by mouth after 10 hours fasting and subject will fast at least 4 hours post-dose

Drug: Mucinex®

Treatment B: Mucinex® 600 mg (fed)

EXPERIMENTAL

Mucinex® 600 mg ER bi-layer tablet by mouth in fed condition. After an overnight fast of at least 10 hours, subjects will consume a high fat, high calorie breakfast starting 30 minutes prior to drug administration

Drug: Mucinex®

Interventions

Mucinex® DRUG

Mucinex® 600 mg ER bi-layer tablets

Also known as: guaifenesin

Treatment A: Mucinex® 600 mg (fast); Treatment B: Mucinex® 600 mg (fed)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent was obtained (i.e. be informed of the nature of the study and given written consent prior to any study procedure). Able to read, understand, and sign the informed consent, after the nature of the study had been explained.
• Age: 18 to 55 years of age, inclusive.
• Sex: male or female.
• Status: Healthy subjects.
• BMI: ≥18.0 and ≤28.0 kg/m2.
• No clinically significant findings in vital signs measurements at screening.
• No clinically significant abnormal laboratory values at screening.
• No clinically significant findings from a 12-lead electrocardiogram (ECG) at screening.
• Had no significant diseases or clinically relevant medical condition in the opinion of the Investigator
• Males who participated in this study were willing to:
• remain abstinent \[not engage in sexual intercourse\] from the start of drug administration until 90 days after the end of the study or
• used (or their partner used, as applicable) two effective methods of birth control \[condom, diaphragm, cervical cap, vaginal sponge, spermicide, IUD, tubal ligation, vasectomy, or hormonal contraceptives\] from the start of drug administration until 90 days after the end of the study.
• Females who participated in this study were:
• unable to have children (e.g., post-menopausal, hysterectomy);
• willing to remain abstinent \[not engage in sexual intercourse\] from 21 days prior to drug administration until 30 days after the end of the study; or

You may not qualify if:

• Employee of Pharma Medica Research Inc. (PMRI) or Reckitt Benckiser.
• Partner or first-degree relative of any Investigator at PMRI.
• Known history or presence of any clinically significant medical condition.
• Known or suspected carcinoma.
• Presence of hepatic or renal dysfunction.
• Presence of clinically significant gastrointestinal disease or history of malabsorption within the year preceding the study.
• Known history or presence of galactose or fructose intolerance, sucrase-isomaltase insufficiency, Lapp lactase insufficiency, galactosemia, or glucose-galactose malabsorption syndrome.
• Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
• History of drug or alcohol or medicinal product addiction requiring treatment within the two years preceding the study or excessive alcohol consumption (more than 10 units per week)
• Note: one unit is defined as 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of spirits.
• Positive test result for serum Human Chorionic Gonadotropin (hCG) consistent with pregnancy (females only), HIV, Hepatitis B surface antigen or Hepatitis C antibody.
• Positive test result for urine drugs of abuse (cannabinoids, opiates, amphetamines, cocaine, phencyclidine, tricyclic antidepressants, barbiturates, methadone and benzodiazepines) or urine cotinine.
• Difficulty fasting or consuming standard meals.
• Females who were lactating.
• Did not tolerate venipuncture.

Sponsors & Collaborators

• Reckitt Benckiser LLC: lead

MeSH Terms

Interventions

Acetylcysteine; Guaifenesin

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Guaiacol; Methyl Ethers; Ethers; Phenyl Ethers; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Clinical Research Director, Clinical Research
• Organization: Reckitt Benckiser Inc.

clinicalrequests@rb.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 28, 2018
• Study Start: May 29, 2013
• Primary Completion: August 7, 2013
• Study Completion: August 7, 2013
• Last Updated: March 27, 2019
• Results First Posted: February 22, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share