An Open-Label, Single-Dose, Two-Way Crossover Bioequivalence Study of Two Oral Suspension Formulations of Amoxicillin/Clavulanate Potassium, 600/42.9 mg/5 mL in Healthy Subjects Under Fasting Conditions

Teva Pharmaceuticals USA1 个研究点分布在 1 个国家目标入组 48 人开始时间: 2002年8月最近更新: 2024年8月20日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Teva Pharmaceuticals USA
入组人数: 48
试验地点: 1
主要终点: Bioequivalence Based on AUC0-inf for Clavulanic Acid

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this study is to assess the bioequivalence between Amoxicillin and Clavulanate Potassium for Oral Suspension, 600/42.9 mg/5 mL and Augmentin ES-600™ for Oral Suspension, 600/42.9 mg/5 mL in healthy, male and female subjects, under 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: Non 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

•Healthy, non-smoking male or non-pregnant, non-lactating female subjects, 18 years of age and over.
•Body weight within ±15% of the appropriate weight range published in 1993 by Metropolitan Life Insurance Company, Statistical Bureau and body-mass index (BMI) less than
•Negative for:
•Hepatitis B and C
•Urine drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
•Cotinine (urine test)
•Breath alcohol (Breathalyzer)
•HCG (females only)
•No significant diseases or clinically significant abnormal laboratory values.
•No clinically significant findings in the physical examination.
•No clinically significant findings in vital sign measurements and 12-lead electrocardiogram (ECG).
•Informed of the nature of the study and give written consent prior to receiving any study medication.
•Female subjects: surgically steril, post-menopausal or practicing a recognized safe method of contraception (abstention, oral or implanted contraceptives, intra-uterine device or consistent condom plus spermicide use).

排除标准

•Known history or presence of any disease or condition which might compromise the following body systems: immunologic, endocrine, renal, cardiovascular, respiratory, hematologic, gastrointestinal, neurologic, hepatic, psychiatric or dermatologic
•More specifically: history or presence of significant: sensitivity to multiple allergens, diarrhea, stomach or intestinal disease, mononucleosis, renal or hepatic dysfunction and asthma.
•Known or suspected carcinoma.
•Known history or presence of:
•Hypersensitivity or idiosyncratic reaction to amoxicillin, clavulanic acid, penicillins, cephalosporins and/or any other β-lactamase inhibitors.
•Clavulin-associated jaundice/hepatic dysfunction.
•Alcoholism within last 12 months.
•Drug dependence and/or substance abuse.
•Use of tobacco or nicotine-containing products, within last 12 months.
•On a special diet within 4 weeks prior to drug administration (i.e. a deliberate change in diet for any reason).
•Participation in another clinical trial or received an investigational product in the previous 30 days prior to drug administration.
•Donation up to 250 mK of blood in the previous 30 days, 251-500 mKL in the previous 45 days, 501-750 mL in the previous 60 days or above 750 mL in the previous 90 days prior to study start.
•Requirement of any medication, (prescription and/or over-the-counter) or dietary supplements on a routine basis, with the exception of occasional use of acetaminophen and oral or implanted contraceptives.
•Difficulty fasting or consuming the standard prescribed meals.

研究组 & 干预措施

1

Experimental

干预措施: 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL (Drug)

2

Active Comparator

干预措施: Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension (Drug)