NCT01671722已完成1 期
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fed 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
- 43
- 试验地点
- 1
- 主要终点
- Area under curve(AUC)
研究概览
简要总结
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
详细描述
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Montelukast sodium tablets 10mg of Dr. Reddy's Laboratories Limited, India comparing with that of SINGULAIR® (containing Montelukast sodium) tablets 10mg of Merck Sharp & Dohme Ltd., USA in healthy, adult, human subjects under fed conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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 were selected based on the following inclusion criteria:
- •Provide written informed consent.
- •Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg.
- •Having a body mass index between 18.0 and 24.9 (both inclusive), calculated as weight in Kg/height in m2 .
- •Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study. (Laboratory values must be within normal limits or considered by the physician / investigator to be of no clinical significance).
- •Female Subjects
- •Of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
- •Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
- •Exclusion Criteria
- •The subjects were excluded based on the following criteria during screening and during the study:
- •Incapable of understanding the informed consent.
- •Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg.
- •Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.
- •Oral temperature is below 95.0°F or above 98.6°F.
- •Pulse rate below 50/min or above 100/min.
- •History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs.
- •Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
- •Consumption of grapefruit for the past ten days prior to the check-in, in each period.
- •Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period.
- •Habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period.
- •Difficulty in abstaining from xanthene containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period.
- •Intake of over the counter (OTC) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing.
- •Clinically significant abnormalities and / or with significant diseases.
- •Confirmed positive in alcohol screening.
- •Confirmed positive in selected drug of abuse.
- •Participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study.
- •Confirmed positive in urine pregnancy test.
- •Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study.
排除标准
- 未提供
研究组 & 干预措施
Montelukast sodium tablets
Experimental
Montelukast sodium tablets 10mg of Dr. Reddy's Laboratories Limited
干预措施: Montelukast sodium (Drug)
SINGULAIR
Active Comparator
(containing Montelukast sodium) tablets 10mg of Merck Sharp & Dohme Ltd., USA
干预措施: Montelukast sodium (Drug)
结局指标
主要结局
Area under curve(AUC)
时间窗: Blood samples were withdrawn at predose (0.00) and 0.50, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post-dose.
次要结局
未报告次要终点
研究者
研究点 (1)
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