Codeine Phosphate/Guaifenesin ER Tablet 30 mg/600 mg Steady State Clinical Study

NCT02572375 | Completed Phase 1 DMC

• 1 other identifier: COGU510
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this pivotal study are:

1. 1.to evaluate bioavailability of an extended-release and immediate release Codeine Phosphate/Guaifenesin tablet at steady state following multiple oral administration
2. 2.to assess the safety and tolerability of this Codeine Phosphate/Guaifenesin extended release formulation.

Conditions

Cough

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (Cmax)

  Determination peak plasma concentration of each active ingredient during 12 hours following six days of dosing

  One week

• Area under the plasma concentration versus time curve (AUC)

  Determination of total area under the plasma concentration versus time curve (AUC) during the 12 hours following 6 days of dosing.

  One week

Study Arms (2)

Codeine Phosphate/Guaifenesin ER Tablet

EXPERIMENTAL

Patients receiving an extended release tablet dosage form of a combination drug of Codeine Phosphate and Guaifenesin twice a day for 6 and a half days total. Total dosage \[2 tablets\] is 60 mg Codeine Phosphate and 1200 mg Guaifenesin twice a day for a daily total of 120 mg Codeine Phosphate and 2400 mg Guaifenesin.

Drug: Codeine Phosphate/Guaifenesin ER Tablet

Codeine Phosphate/Guaifenesin IR Tablet

ACTIVE COMPARATOR

Patients receiving an immediate release tablet dosage form of a combination drug of Codeine Phosphate and Guaifenesin six times a day for 6 and a half days total. Dosage is 20 mg Codeine Phosphate and 400 mg Guaifenesin six times a day for a daily total of 120 mg Codeine Phosphate and 2400 mg Guaifenesin.

Drug: Codeine Phosphate/Guaifenesin IR Tablet

Interventions

Codeine Phosphate/Guaifenesin ER Tablet DRUG

Provide two Codeine Phosphate and Guaifenesin ER Tablet every 12 hours for 6 1/2 days.

Also known as: Lot 100171

Codeine Phosphate/Guaifenesin ER Tablet

Codeine Phosphate/Guaifenesin IR Tablet DRUG

Provide one Codeine Phosphate and Guaifenesin IR Tablet every 4 hours for 6 1/2 days

Also known as: Lot 100168

Codeine Phosphate/Guaifenesin IR Tablet

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 (minimum of 50 kg weight);
• 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) year
• Normal 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
• Pharmaceutical Research Unit, Jordan: collaborator

Study Sites (1)

Pharmaceutical Research Unit

Amman, 11910, Jordan

Location

MeSH Terms

Conditions

Cough

Interventions

Codeine

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

Study Officials

• Rana T Bustami, PhD

  Pharmaceutical Research Unit, Jordan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: October 8, 2015
• Study Start: October 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

JO (1)