NCT00834197已完成1 期
A Relative Bioavailability Study of 15 mg Mirtazapine Orally Disintegrating Tablets Under Non-Fasting Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
研究概览
简要总结
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 non-fasting conditions.
详细描述
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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).
排除标准
- •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.
研究组 & 干预措施
1
Experimental
干预措施: Mirtazapine 15 mg (Orally Disintegrating) Tablets (Drug)
2
Active Comparator
干预措施: REMERON SolTab® 15 mg Orally Disintegrating Tablets (Drug)
结局指标
主要结局
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
时间窗: Blood samples collected over a 120 hour period.
Bioequivalence based on Cmax.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
时间窗: Blood samples collected over a 120 hour period.
Bioequivalence based on AUC0-inf.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
时间窗: Blood samples collected over a 120 hour period.
Bioequivalence based on AUC0-t.
次要结局
未报告次要终点
研究者
研究点 (1)
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