The Relative Bioavailability of Two Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Cmax - Maximum Observed Concentration - Terbinafine in Plasma
研究概览
简要总结
The Purpose of this study os to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under post-prandial conditions in healthy, non-tobacco using male and female adult subjects.
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
- •Males and females, 18 years or older inclusive with a body mass index (BMI) of 30 or less.
- •Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
- •Signed and dated informed consent form, which meets all criteria of current FDA regulations
- •If female and of child bearing potential subjects must be prepared to abstain from sexual intercourse or use a reliable barrier method of contraception (e.g. condom, IUD) during the duration of the study. Female subjects who have used oral contraceptives within 14 days or injected hormonal contraceptives within 180 days of dosing will not be allowed to participate.
排除标准
- •If female, pregnant, lactating or likely to become pregnant during the study.
- •History of allergy or sensitivity to terbinafine, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
- •Significant history or current evidence of chronic evidence of chronic infectious disease, system disorder ot organ dysfunction.
- •Presence of gastrointestinal disease ot history of malabsorption within the last year.
- •History of psychiatric disorders occuring within the last two years that required hospitalization or medication.
- •Presence of a medical condition requiring regular treatment with prescription drugs.
- •Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes. within 30 days prior to dosing.
- •Receipt of any drug as part of a research study within 30 days prior to dosing.
- •Drug or alcohol addition requiring treatment in the past 12 months.
- •Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing.
- •Positive test results for drug of abuse at screening.
- •Tobacco user within 90 days of the first study dose.
- •Unable, or unwilling to tolerate multiple venipunctures.
研究组 & 干预措施
Terbinafine
Terbinafine 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
干预措施: Terbinafine HCl 250mg tablets (Drug)
Lamisil®
Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
干预措施: Lamisil® 250 mg Tablets (Drug)
结局指标
主要结局
Cmax - Maximum Observed Concentration - Terbinafine in Plasma
时间窗: Blood samples collected over144 hour period
Bioequivalence based on Cmax
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Terbinafine in Plasma
时间窗: Blood samples collected over 144 hour period
Bioequivalence based on AUC0-t
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma
时间窗: Blood samples collected over 144 hour period
Bioequivalence based on AUC0-inf
次要结局
未报告次要终点