Single Dose Trial of Extended Release Combination Tablet Codeine and Guaifenesin

• Register: ClinicalTrials.gov
• Last refreshed on: 28 April 2015
• Main ID: NCT02157649
• Date of registration: 04/06/2014
• Prospective Registration: No
• Primary sponsor: Nexgen Pharma, Inc
• Public title: Single Dose Trial of Extended Release Combination Tablet Codeine and Guaifenesin
• Scientific title: An Open-Label, Single-Dose, Crossover Comparative Bioavailability and Pharmacokinetic Study of Codeine Phosphate/Guaifenesin Extended-Release Tablet With Immediate-Release Tablet
• Date of first enrolment: June 2014
• Target sample size: 26
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02157649
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Jordan

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

- History of low blood pressure is deemed by the Investigator to be clinically
significant;

- A positive Hepatitis B surface antigen, Hepatitis C antibody screen, or a reactive
HIV antibody screen;

- Known or suspected hypersensitivities, allergies, or other contraindications to
Codeine or a related opioid and/or Guaifenesin;

- History of severe allergy or allergic reactions to study drug or related drugs or
heparin

- Known history or presence of food allergies, or any condition known to interfere with
the absorption, distribution, metabolism or excretion of drugs

- Known or suspected history of drug abuse within lifetime as judged by the
Investigator;

- History of alcohol abuse or excessive intake of alcohol within last 5 years as judged
by the Investigator;

- Positive screen for drugs of abuse, alcohol, or cotinine (nicotine) at
screening or on admission to the unit prior to administration of investigational
products;

- Use of drugs that induce or inhibit the hepatic metabolizing cytochrome P450
2D6 enzymes, within 30 days prior to administration of study formulations.
Examples of inducers include: piperidins, carbamazepine, dexamethasone, rifampin.
Examples of inhibitors include: cimetidine, diphenhydramine,
fluvastatine, methadone, and ranitidine;

- Use of prescription medications within 21 days and OTC medications (including
vitamins or herbal products) within 7 days (excluding flu vaccination) prior to
the first administration of the study medication without Sponsor approval;

- Intake of Alcohol, caffeine, or xanthine beverages 16 hrs before each study drug
administration.

- Use of any investigational drug within 30 days prior to first dosing;

- Use of any tobacco-containing product within 6 months of first dosing;

- Donated more than 400 mL of blood within 4 weeks before first dosing;

- Participation in another bioequivalence study and/or Clinical trials within 80 days
prior to the start of this study Period I

- Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent
significant change in dietary or exercise habits.

- Abnormal vital signs

- Abnormal Kidney and Liver functions test.

- In the opinion of the Investigator, unlikely or unable to successfully complete the
study;

- Volunteer is vegetarian.

- Vomiting, Diarrhea on admission.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cough

Intervention(s)

Drug: IR Tablet under Fasted conditions

Drug: ER Tablet under Fed Conditions

Drug: ER Tablet under Fasted Conditions

Primary Outcome(s)

Serum Levels of Codeine and Guaifenesin [Time Frame: 20 samples over 24 hours]

Secondary Outcome(s)

Safety and Tolerability [Time Frame: 24 hours]

Secondary ID(s)

COGU506

Source(s) of Monetary Support

Please refer to primary and secondary sponsors