Randomized, 2-Way Crossover, Bioequivalence Study of Teva Pharmaceuticals USA and Merck Sharp & Dohme (USA) (Fosamax®) Alendronate Sodium Tablets Administered as a 1 x 70 mg in Healthy Adult Males Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Bioequivalence Based on Rmax
研究概览
简要总结
The objective of this study is to compare the rate and extent of absorption of alendronate sodium 70 mg tablets (test) versus Fosamax® 70 mg tablets (reference) administered as a single dose of 70 mg under fasting conditions. A review of pharmacokinetic data demonstrates Alendronate Sodium Tablets, 70 mg, manufactured and distributed by TEVA Pharmaceuticals USA are bioequivalent to Fosamax® Tablets, 70 mg, manufactured by Merck Sharp & Dohme, USA.
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
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects will be males, non-smokers, between 18 and 45 years of age.
- •Subjects' weight will be within 15% of their ideal body weight based on the Table of "Desirable Weight of Adults", Metropolitan Life Insurance Company, 1983
- •Subjects should read, sign, and date an Informed Consent Form prior to any study procedures.
- •Subjects must complete all screening procedures within 28 days prior to the administration of study medication.
排除标准
- •Clinically significant abnormalities found during medical screening.
- •Any history or presence of significant neurological, hepatic, renal, endocrine, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
- •Any clinically significant history of ongoing gastrointestinal problems or problems known to interfere with the absorption, distribution, metabolism or excretion of drugs (e.g. chronic diarrhea, inflammatory bowel diseases).
- •Clinically significant illnesses within 4 weeks of the administration of study medication.
- •Abnormal laboratory tests judged clinically significant.
- •ECG or vital signs abnormalities (clinically significant).
- •History of allergic reactions to alendronate or other related drugs (e.g. clodronate, etidronate and pamidronate).
- •History of allergic reactions to heparin.
- •Any food allergies, intolerances, restrictions, or special diet which in the opinion of the medical subinvestigator, contraindicates the subject's participation in this study.
- •Positive urine drug screen at screening or at check-in of period I.
- •Positive testing for hepatitis B, hepatitis C or HIV at screening.
- •Use of an investigational drug or participation in an investigational study, within 30 days prior to administration of the study medication.
- •Recent donation of plasma (500 mL) within 7 days or recent donation or significant loss of whole blood (450 mL) within 56 days prior to administration of the study medication.
- •History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit = 150mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
- •Recent history of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana, pot) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP), crack) within 1 year of the screening visit.
- •Subjects who have used tobacco within 90 days of the start of the study.
- •Subjects who have taken prescription medication 14 days preceding administration of study medication or over-the-counter products 7 days preceding administration of study medication, except for topical products without systemic absorption.
- •Subjects who have taken any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine).
- •Subjects who have undergone clinically significant surgery 4 weeks prior to the administration of the study medication.
- •Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
研究组 & 干预措施
Alendronate Sodium First
70 mg Alendronate Sodium Tablets test product dosed in first period followed by 70 mg Fosamax® Tablets reference product dosed in second period
干预措施: Alendronate Sodium Tablets 70mg (Drug)
Fosamax® First
70 mg Fosamax® Tablets reference product dosed in first period followed by 70 mg Alendronate Sodium Tablets test product dosed in second period.
干预措施: Fosamax® Tablets 70mg (Drug)
结局指标
主要结局
Bioequivalence Based on Rmax
时间窗: Urine collected over 36 hour period
Rmax = maximum rate of urinary excretion
Bioequivalence Based on Ae0-36
时间窗: Urine collected over 36 hour period
Ae0-36 = cumulative urine excretion
次要结局
未报告次要终点