Overview

Single Dose Trial of Extended Release Combination Tablet Codeine and Guaifenesin

Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Nexgen Pharma, Inc
Treatments:
Chlorpheniramine, phenylpropanolamine drug combination
Codeine
Guaifenesin
Phenylpropanolamine
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.