15 mg Mirtazapine Orally Disintegrating Tablets, Fasting

Study Overview
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Brief Summary
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This study will compare the relative bioavailability (rate and extent of absorption) of 15 mg Mirtazapine (Orally Disintegrating) Tablets manufactured by TEVA Pharmaceutical Industries, Ltd.; distributed by TEVA Pharmaceuticals USA with that of 15 mg REMERON SolTab® Orally Disintegrating Tablets manufactured for Organon Inc. by CIMA Labs Inc. following a single oral dose (1 x 15 mg) in healthy adult subjects under fasting conditions.

Detailed Description
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Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Official Title
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A Relative Bioavailability Study of 15 mg Mirtazapine Orally Disintegrating Tablets Under Fasting Conditions

Conditions
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Healthy

Intervention / Treatment
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* Drug: Mirtazapine 15 mg (Orally Disintegrating) Tablets
* Drug: REMERON SolTab® 15 mg Orally Disintegrating Tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Screening Demographics: All subjects selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The subject's body mass index (BMI) should be less than or equal to 30. Screening Procedures: Each subject will complete the screening process within 28 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 fill 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 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, hepatitis B surface antigen, and hepatitis C antibody screens; Urinalysis: by dipstick; full microscopic examination of dipstick positive; and Urine Drug Screen: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine. Serum Pregnancy Screen (female subjects 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; or is postmenopausal for at least 1 year; or is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). Exclusion Criteria: Subjects with a recent history of drug or alcohol addiction or abuse. Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators). Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant. Subjects demonstrating a positive hepatitis B surface antigen screen, hepatitis C antibody screen, or a reactive HIV antibody screen. Subjects demonstrating a positive pregnancy screen. Subjects who are currently breastfeeding. Subjects with a history of clinically significant allergies including drug allergies. Subjects with a history of allergic response(s) to mirtazapine or related drugs. Subjects with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators). Subjects who currently use of have used tobacco products within 90 days of Period I dosing. Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing. Subjects who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study. Subjects 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. Subjects who report receiving any investigational drug within 28 days prior to Period I dosing. Subjects who report taking any systemic prescription medication in the 14 days prior to Period I dosing. Subjects who report an intolerance of direct venipuncture. Subjects who report consuming an abnormal diet during the 28 days prior to Period I dosing.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Mirtazapine 15 mg (Orally Disintegrating) Tablets<br>* 1 x 15 mg, single-dose fasting<br>|
| Active Comparator: 2<br> | Drug: REMERON SolTab® 15 mg Orally Disintegrating Tablets<br>* 1 x 15 mg, single-dose fasting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (Maximum Observed Concentration of Drug Substance in Plasma) | Bioequivalence based on Cmax. | Blood samples collected over a 120 hour period. | 
| AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Bioequivalence based on AUC0-t. | Blood samples collected over a 120 hour period. | 
| AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) | Bioequivalence based on AUC0-inf. | Blood samples collected over a 120 hour period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Healthy Subjects