Cough Clinical Trial
— COGUSSOfficial title:
An Open-Label, Randomized, Multiple-Dose, 2-Way Crossover Comparative Bioavailability Steady State Study of Codeine Phosphate/Guaifenesin Extended-Release Tablet in Healthy Subjects
Verified date | March 2017 |
Source | Nexgen Pharma, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objectives of this pivotal study are:
1. to evaluate bioavailability of an extended-release and immediate release Codeine
Phosphate/Guaifenesin tablet at steady state following multiple oral administration
2. to assess the safety and tolerability of this Codeine Phosphate/Guaifenesin extended
release formulation.
Status | Completed |
Enrollment | 38 |
Est. completion date | January 2015 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
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 (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. 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 48 before each study drug administration, and caffeine, or xanthine beverages 24 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. |
Country | Name | City | State |
---|---|---|---|
Jordan | Pharmaceutical Research Unit | Amman |
Lead Sponsor | Collaborator |
---|---|
Nexgen Pharma, Inc | Pharmaceutical Research Unit, Jordan |
Jordan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak Plasma Concentration (Cmax) | Determination peak plasma concentration of each active ingredient during 12 hours following six days of dosing | One week | |
Primary | 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 |
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