A balance, open lable, analyst bind, two treatment, two sequence, single dose bioequivalence study of Seratrodast 80 mg of Zuventus Healthcare Ltd. with BRONICA of Tekeda Pharmaceuticals in 26 healthy, adult, male, human subjects under fasting conditions in randomised, crossover design.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Seratrodast 80 mgis Bioequivalent to BRONICA 80 mg
研究概览
简要总结
This study was designed to evaluate bioequivalence study of Seratrodast tablets 80 mg for oral administration manufactured by Zuventus Healthcare Limited with
BRONICA® Tablets for oral administration manufactured by Takeda Pharmaceuticals ‘
i. Target population for study: Healthy, adult, male, human subjects.
A Treatment: Two
Test Product: Seratrodast tablets 80 mg.
Reference Product: BRONICA® Tablets.
Duration of clinical study: 19 days.
STUDY OBJECTIVE was to compare the rate and extent of absorption of single-dose of Seratrodast tablets 80 mg of Zuventus Healthcare Ltd. with BRONICA (Seratrodast tablets 80 mg) of Takeda Pharmaceuticals in healthy, adult, male, human subjects under fasting conditions in healthy, adult, male, human subjects under fasting conditions in a randomized crossover design AND to evaluate the safety of single dose of Seratrodast tablets 80 mg
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
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 humans within 18 to 45 2 weight at least 45 and BMI in range of18.
- •25.9 3 normal health as determined by medical history and clionical examination, laboratory and othe test mentioned within normal range 5 willingness to provide writtent informed consent to participate in the study 6 willingness to comply with the requirement of protocol including all the restrictions 7 availability of subject during the entire study period.
排除标准
- •1 history of allergy or hypersensitivity to investigational drug 2 abnormilities in vital signs systolic blood pressure < 90 or > 140 mmHg and diostolic blood pressure <50 or >90 mmHg or heart rate <50 bpm or > 100 bpm at screening, pre entry and at pre dose physiccal examination 3 clinically significant cardiovascular, gastrointestinal, liver, renal, pulmonary, hematological, neurological, endocrinal disease 4 History of epilepsy or psychiatric disorder 5 Any illness within 21 days or hospitalized or major illness within three months prior to the first dosing 6 Any other clinical conditions which may be affect absorption, distribution biotransformation or excretion of the study drug 7 Use of any priscribed medication within last two weeks or OTC medical product within last one week preceding first dosing 8 Participated in any other clinical investigation requiring repeted blood sampling/ blood donation program/ have blood lose more than 350 ml from past 90 days 9 History of consumtion of alcohol for more than two years or drink more than two alcohol drinks in a day or consumed alcohol within 48 hrs prior to dosing 10 Smoke more than 10 cigaretts per day or unable to abstain from smoking during study period 11 Consumtion of product containing xanthin and nicotin within 48 hrs before dosing 12 Intake of grapefruits or product containg grape fruits within 72 Hrs prior to receiving the dose of study medication in each period 13 An unusal diet for whatever reson for four weeks prior to receiving study medication 14 Use of any recreational drug or history of drug addiction 15 History of difficulty in vein accessibility.
结局指标
主要结局
Seratrodast 80 mgis Bioequivalent to BRONICA 80 mg
时间窗: 17 days
次要结局
- No adverse reaction observed during the study period(19 days)