Single Dose Trial of Extended Release Combination Tablet Codeine and Guaifenesin

NCT02157649 | Completed Phase 1

• 1 other identifier: COGU506
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are (a) to determine if drug levels from a single dose of an extended-release Codeine/Guaifenesin tablet are similar to an immediate-release tablet given every four hours containing lower doses considered safe for over-the-counter use; (b) to evaluate if food affects the drug levels of this extended-release Codeine/Guaifenesin tablet after a single administration; and (c) to assess the safety and tolerability of the Codeine/Guaifenesin extended-release and immediate release tablet formulations.

Conditions

Cough

Outcome Measures

Primary Outcomes (1)

• Serum Levels of Codeine and Guaifenesin

  Blood samples drawn prior to dosing with tablets, then at 19 additional time points over the next 24 hours.

  20 samples over 24 hours

Secondary Outcomes (1)

• Safety and Tolerability

  24 hours

Study Arms (3)

ER Tablet under Fasted Conditions

EXPERIMENTAL

Administration of a single dose of two ER Tablets, combination of Codeine/Guaifenesin 30gm/600mg, to subjects under fasted conditions.

Drug: ER Tablet under Fasted Conditions

IR Tablet under Fasted conditions

ACTIVE COMPARATOR

IR Tablet combination tablet of Codeine/Guaifenesin 20mg/400mg administered under fasted conditions as a single tablet every 4 hours during a 12 hour study \[three doses\]

Drug: IR Tablet under Fasted conditions

ER Tablet under Fed Conditions

EXPERIMENTAL

Administration of a single dose of two ER Tablets, combination of Codeine/Guaifenesin 30gm/600mg, following a standard high-fat breakfast.

Drug: ER Tablet under Fed Conditions

Interventions

IR Tablet under Fasted conditions DRUG

Administration of IR Tablets combination of Codeine Phosphate/Guaifenesin 20mg/400mg every 4 hours for 12 hours total.

Also known as: Codeine Phosphate/Guaifenesin 20mg/400mg

IR Tablet under Fasted conditions

ER Tablet under Fed Conditions DRUG

Administration of two ER Tablet combination of Codeine Phosphate/Guaifenesin 30mg/600mg

Also known as: Codeine Phosphate/Guaifenesin 30mg/600mg ER Tablet

ER Tablet under Fed Conditions

ER Tablet under Fasted Conditions DRUG

Administration of two Codeine Phosphate/Guaifenesin 30mg/600mg ER Tablets under fasted conditions.

Also known as: Codeine Phosphate/Guaifenesin 30mg/600mg ER Tablet

ER Tablet under Fasted Conditions

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy non-smoking volunteers (Female volunteers on a stable contraceptive medication regimen (\> 3 months) may continue during the course of the study but its use must be documented), 18 to 45 years of age, inclusive; Ethnic Group: Arab \& Mediterranean.
• Race: Mixed skin (white \& black skin people).
• Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive;
• willing and able to comply with the appropriate instructions necessary to complete the study, and;
• Fully informed of the risks of entering the study and willing to provide written informed consent.
• Subject is available for the whole study period and gave written informed consent
• If female, must be practicing abstinence or using a medically acceptable form of contraception (e.g., intrauterine device, hormonal birth control \[continuously used for at least 3 months before first dose\], or double barrier method). For the purpose of this study, all females are considered to be of childbearing potential unless they have been post - menopausal, biologically sterile, or surgically sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) for more than one (1) yearNormal Physical examination.
• Vital signs within normal ranges.
• All laboratory screening results within the normal range, or being assessed as clinically Non-significant by the attending physician.
• Normal Kidney and Liver functions test.

You may not qualify if:

• Women of childbearing potential who don't use any contraceptive method, pregnant and/or lactating women.
• Ethnic Group (Non- Arab \&/ or Non- Mediterranean)
• A significant abnormality in the pre-study physical examination that would place the volunteer at risk during participation in the trial;
• A clinical laboratory test value outside of the accepted reference range that is deemed by the Investigator to be clinically significant;
• Require prescription medication on a regular basis;
• A clinically significant illness during the 28 days prior to Period 1 dosing (as determined by the Investigator);
• History of serious illness that can impact fate of drugs
• History of gastrointestinal obstruction, constipation, inflammatory bowel disease, gallbladder disease, pancreas disorder over last 2 years, or recent (over last 3 years) gastrointestinal tract surgery, including gall bladder resection;
• Known history or presence of cardiac, pulmonary, endocrine, musculoskeletal, neurological, hematological or disease.
• Subjects with acute pulmonary insufficiency, respiratory depression, acute or chronic severe respiratory insufficiency or history of any of these
• History of head injury, seizures over last 4 years deemed by the Investigator to be clinically significant;
• Mental disease
• History of kidney disease or urination problem over last 2 years deemed by the Investigator to be clinically significant
• Subjects with renal and/or hepatic insufficiency should be excluded
• Presence of any significant physical or organ abnormality

Sponsors & Collaborators

• Nexgen Pharma, Inc: lead

Study Sites (1)

Pharmaceutical Research Unit

Amman, 11910, Jordan

Location

MeSH Terms

Conditions

Cough

Interventions

Codeine; Guaifenesin

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Guaiacol; Methyl Ethers; Ethers; Organic Chemicals; Phenyl Ethers; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

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

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 6, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

JO (1)