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Trial record 7 of 490 for:    guaifenesin | Completed Studies

Study to Evaluate Drug-drug Interactions of Guaifenesin and Hydrocodone Bitartrate

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ClinicalTrials.gov Identifier: NCT03642873
Recruitment Status : Completed
First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC

Brief Summary:
Determine and compare the plasma concentrations and safety and tolerability of Guaifenesin and hydrocodone bitartrate when they are administered alone or in combination to normal healthy male and/or female subjects.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Humibid® Drug: Hydrocodone Bitartrate Drug: Humibid® and Hydrocodone Bitartrate tablet Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Study Designed to Examine the Potential for a Drug-drug Interaction Between Guaifenesin and Hydrocodone Bitartrate in Normal Healthy Volunteers
Actual Study Start Date : May 5, 2007
Actual Primary Completion Date : May 21, 2007
Actual Study Completion Date : May 21, 2007


Arm Intervention/treatment
Experimental: Treatment A
Guaifenesin (Humibid®) single extended release 1200 mg tablet administered with 240 mL of room temperature water under fasted conditions.
Drug: Humibid®
Humibid® 1200 mg (single extended release) tablet
Other Name: Guaifenesin

Experimental: Treatment B
Hydrocodone Bitartrate of 10 mg in 3 oral doses of a single 3.33 mg tablet in three intervals administered with 240 mL of room temperature water in the fasted state.
Drug: Hydrocodone Bitartrate
Hydrocodone Bitartrate (3.33 mg q4h X 3)

Experimental: Treatment C
Hydrocodone Bitartrate 10 mg in 3 oral doses of a single 3.33 mg tablet in three intervals and guaifenesin (Humibid®) 1200 mg ER administered with 240 mL of room temperature water in the fasted state.
Drug: Humibid® and Hydrocodone Bitartrate tablet
Humibid® 1200 mg (single extended release) tablet and Hydrocodone bitartrate (3.33 mg q4h X 3)




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of guaifenesin [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose ]
  2. Area under plasma concentration-time curve from time 0 to the last measurable concentration (AUC(0-t)) of guaifenesin [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose ]
  3. Area under plasma concentration-time curve from time 0 to infinity (AUC(0-inf)) of guaifenesin [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose ]
  4. Apparent terminal elimination rate constant (Kel) of guaifenesin [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose ]
  5. Time to maximum observed concentration (Tmax) of guaifenesin [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose ]
  6. Apparent terminal elimination half-life (T1/2) of guaifenesin [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose ]

Secondary Outcome Measures :
  1. Number of Adverse Events (AEs) [ Time Frame: Upto Day 17 ]


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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

    • Intrauterine device (IUD) in place for at least 3 months prior to study;
    • Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through 30 days beyond study completion;
    • Stable hormonal contraceptive for at least 3 months prior to study through 30 days beyond completion of study;

    Abstinence was not an acceptable form of contraception.

    Females of non-childbearing potential were surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 3 months prior to study) or postmenopausal <2 years. An FSH >40 mIU/mL was obtained and in the record.

  3. Good general health was determined by medical history, physical examination, electrocardiogram (ECG), and clinical laboratory measures.
  4. Within 15% of Ideal Body Weight as defined by the 1983 Metropolitan Life chart.
  5. Non-tobacco users, who had not used nicotine or nicotine-containing products for at least 1 year.
  6. Able to read, understand, and sign the informed consent after the nature of the study had been explained.
  7. Negative finding on tests for Hepatitis B and C antigen as well as HIV and pregnancy test (if female).
  8. Negative urine screen for drugs of abuse and alcohol at screening and the first check in.
  9. Non-alcohol or drug abuser - for alcohol, defined as history of less then 4 drinks daily.

Exclusion Criteria:

  1. Clinically significant abnormalities detected by medical history, physical, ECG, or clinical laboratory findings (as determined by the Principal Investigator). Any disease or condition which impacted absorption, distribution, metabolism, or elimination of the study drugs.
  2. Females who were pregnant or nursing.
  3. History of hypersensitivity reaction to the study drugs or related compounds, such as other opioids.
  4. Receipt of an investigational drug within 1 month prior to study enrollment.
  5. Donation of blood or significant loss of blood within 56 days or plasma within 14 days prior study enrollment.
  6. Known or suspected use of illicit drugs (including codeine or hydrocodone, etc.).
  7. The use of any medication on a chronic basis with the exception of oral contraceptives for women of childbearing potential. An appropriate drug-free period for prescription or over-the-counter (OTC) drugs provided to washout any especially long half-life drugs.
  8. Consumption of alcohol within 48 hours prior to each dosing period.
  9. Consumption of grapefruit 14 days prior to dosing and throughout the study.
  10. Hemoglobin value < 12 g/dL. If a subject's hemoglobin dropped below 11.0 g/dL the subject was dropped from the study at the Principal Investigator's discretion.

Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT03642873     History of Changes
Other Study ID Numbers: 2006-HYDRO-04
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Guaifenesin
Antitussive Agents
Hydrocodone
Phenylpropanolamine
Chlorpheniramine, phenylpropanolamine drug combination
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Respiratory System Agents
Expectorants
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Nasal Decongestants
Vasoconstrictor Agents