Mucinex® ER 600 mg Bi-layer Tablet Versus Guaifenesin Immediate Release (IR) 200 mg q4h

NCT03642262 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 2013-MUC-02
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Demonstrate bioequivalence of guaifenesin in Mucinex® extended release (ER) 600 mg tablet in normal healthy volunteers compared to the immediate release guaifenesin 200 mg tablet reference product marketed

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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours

• Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable 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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours

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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours

• 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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours

• 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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours

• 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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours

• 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, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours

Study Arms (2)

Treatment A: Mucinex® ER 600 mg

EXPERIMENTAL

Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition.

Drug: Mucinex®

Treatment B: Guaifenesin 200 mg

ACTIVE COMPARATOR

Guaifenesin 200 mg immediate release (IR) tablet thrice (at 0, 4, and 8 hours) by mouth under fasting condition.

Drug: Mucinex®

Interventions

Mucinex® DRUG

Mucinex® 600 mg single dose ER bi-layer tablet

Also known as: guaifenesin

Treatment A: Mucinex® ER 600 mg; Treatment B: Guaifenesin 200 mg

Eligibility Criteria

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

You may qualify if:

• Informed consent has been obtained (i.e. be informed of the nature of the study and give written consent prior to any study procedure). Able to read, understand, and sign the informed consent, after the nature of the study has 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.
• Have no significant diseases or clinically relevant medical condition in the opinion of the investigator.
• Males who participate in this study are 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
• use (or their partner will use, 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 participate in this study are:
• 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:

• Subjects to whom any of the following conditions apply must be excluded:
• 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 last year.
• 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 past two years 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 are lactating.
• Does not tolerate venipuncture.

Sponsors & Collaborators

• Reckitt Benckiser Inc.: 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

Model Details: 2-Way Crossover

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: June 2, 2013
• Primary Completion: August 9, 2013
• Study Completion: August 9, 2013
• Last Updated: June 17, 2019
• Results First Posted: June 17, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share