A Relative Bioavailability Study of Mirtazapine 15 mg Tablets Under Fasting Conditions

Inclusion Criteria: * Screening Demographics: All volunteers selected for this study will be healthy men and women 18 years of age or older at the time of dosing. The weight range will not exceed ± 20% for height and body frame as per Desirable Weights for Men -1983 Metropolitan Height and Weight Table or as per Desirable Weights for Women - 1983 Metropolitan Height and Weight Table. * Screening Procedures: Each volunteer will complete the screening process within 30 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures. * Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. -The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems. * The screening clinical laboratory procedures will include: * HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential; RBC count, platelet count * CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase; * HIV antibody and hepatitis B surface antigen screens; * URINALYSIS: by dipstick, microscopic examination if dipstick positive; and . * URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine. * SERUM PREGNANCY SCREEN (female volunteers only) * If female and: * of childbearing potential, is practicing an acceptable barrier method of birth control for the duration of the study as judged by the investigator(s), such as condoms, sponge, foams, jellies, diaphragm; intrauterine device (IUD), or abstinence * is postmenopausal for at least I year; or * is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) Exclusion Criteria: * Volunteers with a recent history of drug or alcohol addiction or abuse. * Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the medical investigator). * Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant. * Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen. * Volunteers demonstrating a positive drug abuse screen when screened for this study. * Female volunteers demonstrating a positive pregnancy screen. * Female volunteers who are currently breastfeeding. * Volunteers with a history of allergic response(s) to mirtazapine or related drugs. * Volunteers with a history of clinically significant allergies including drug allergies. * Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the medical investigator). * Volunteers who currently use tobacco products. * Volunteers who have taken any drug known to induce or inhibit hepatic• drug metabolism in the 30 days prior to Period I dosing. * Volunteers who report donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects will be advised not to donate blood for - Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study. * Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing. * Volunteers who report taking any systemic prescription medication in the 14 days prior to Period I dosing.