CTRI/2018/04/013202已完成1 期
An open label, balanced, analyst blind, randomized, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Fenspiride hydrochloride extended release tablets 80 mg of Zuventus Healthcare Ltd. (A JV Company of Emcure Pharmaceuticals Ltd.) with Pneumorel® 80mg (Fenspiride hydrochloride tablets 80 mg) of Servier, France in normal, healthy, adult, human subjects under fasting condition.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- C max,AUC 0-t, AUC 0-inf
研究概览
简要总结
An open label, balanced, analyst blind, randomized, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Fenspiride hydrochloride extended release tablets 80 mg of Zuventus Healthcare Ltd. (A JV Company of Emcure Pharmaceuticals Ltd.) with Pneumorel® 80mg (Fenspiride hydrochloride tablets 80 mg) of Servier, France in normal, healthy, adult, human subjects under fasting condition.
Total Number of subjects participated 24 healthy human
objective is to compare single dose oral bioavailability profile of test product Fenspiride with pneumorel and to monitor safety
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy human subjects within
- •45 years of age (both inclusive). 2.Non-pregnant, non-lactating (for females) 3.Body Mass Index of ≥ 18.5 kg/m2 and ≤ 24.9 kg/m
- •4.Absence of significant disease or clinically significant abnormal laboratory values or laboratory evaluation, medical history or clinical examination. 5.Have a normal 12-lead ECG or one with abnormality considered to be clinically insignificant. 6.Have a normal chest X-ray PA view (if done) 7.Willingness to provide written informed consent to participate in the study, ability to comprehend the nature and purpose of the study. 8.Willingness to comply with the requirement of the protocol including all the restrictions. 9.Availability of subject for the entire study period.
排除标准
- •1.History of allergy or hypersensitivity to Investigational Product or to its excipients.
- •2.Clinically significant systemic or local disease.
- •3.History of epilepsy or psychiatric disorder.
- •4.Any illness within 21 days or hospitalized or a major illness within the 3 months prior to commencement of the study.
- •5.Any other clinical condition, which may affect the absorption, distribution, biotransformation or excretion of the study drug.
- •6.Presence of any of disease markers of HIV – 1 and 2, hepatitis B, C virus.
- •7.Use of any prescribed medication (including herbal or vitamin supplements) during last two weeks or OTC medical products during the last one week preceding the commencement of the study.
- •8.Participated in any other clinical investigation requiring repeated blood sampling / a blood donation program / have blood loss of more than 350 mL in the past 90 days 9.History of consumption of alcohol for more than two years & drink more than two alcoholic drinks per day or consumed alcohol within 48 hours prior to commencement of the study or difficulty in abstaining alcohol for the duration of the study.
- •[one drink is equal to one unit of alcohol (one glass wine, half pint beer and one measure i.e. one fluid ounce of spirit)] 10.Smoke more than 10 cigarettes / day or Unable to abstain from smoking during the study.
- •11.Consumption of products containing xanthine & nicotine within 48 hours prior to commencement of the study.
- •12.Intake of grapefruits or products containing grapefruits within 72 hours prior to commencement of the study.
- •13.Any significant diet change (eg.
- •low sodium diet) within four weeks prior commencement of the study.
- •14.Use of any recreational drug or a history of drug addiction.
- •15.History of difficulty in accessibility of veins in arms.
- •16.Female subjects not confirming to using birth control measures, from the date of screening until the completion of the last period of the study.
- •[Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable].
- •17.Use of hormonal contraceptives either oral or implants.
结局指标
主要结局
C max,AUC 0-t, AUC 0-inf
时间窗: 1.00 Hrs, 2.00 Hrs, 3.00 Hrs, 4.00 Hrs, 4.50 Hrs, 5.00 Hrs, 5.50 Hrs, 6.00 Hrs, 6.50 Hrs, 7.00 Hrs, 7.50 Hrs, 8.00 Hrs, 9.00 Hrs, 10.00 Hrs, 12.00 Hrs, 16.00 Hrs, 24.00 Hrs, 36 Hrs, 48.00 Hrs
次要结局
- Tmax, T1/2, Kel(1.00 Hrs, 2.00 Hrs, 3.00 Hrs, 4.00 Hrs, 4.50 Hrs, 5.00 Hrs, 5.50 Hrs, 6.00 Hrs, 6.50 Hrs, 7.00 Hrs, 7.50 Hrs, 8.00 Hrs, 9.00 Hrs, 10.00 Hrs, 12.00 Hrs, 16.00 Hrs, 24.00 Hrs, 36 Hrs, 48.00 Hrs)
研究者
研究点 (1)
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