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

• 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.