A randomized, open label, balanced, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Test product (T): Vonoprazan Tablets 20 mg of Eris Lifesciences Limited, India with Reference product (R): Takecab® Tablets 20 mg of Takeda Pharmaceutical Company Limited, 1-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo, Japan, in healthy, adult, human subjects under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
研究概览
简要总结
A single oral dose of Test product (T) or Reference product (R) will be administered as per randomization schedule with 240 mL ± 2 mL of water at ambient temperature under fasting condition.
Before every post dose blood sample collection, 0.2 mL of heparinized blood present in the intravenous cannula will be discarded during the use of the intravenous cannula. Also, after every blood sample collection, 0.2 mL of heparinized saline will be injected into the intravenous cannula.
Total number of blood samples: 22 samples per period.
Sampling: Pre dose 00.00 hr. [(4 mL) collected within 01.00 hour prior to dosing] and post dose of 4 mL at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 16.00, 24.00 and 48.00 hrs. Post-dose. Blood samples will collected in K2EDTA Vacutainer. Blood samples after 24.00 hrs. will be collected on ambulatory basis.
Considering the minimum washout period 07 days, expected study duration of clinical part is 11 days from the day of check-in of first period till the day of last period study sample
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy human subjects (Male and female), age in the range of
- •45 years both inclusive.
- •Body Mass Index between 18.5-30.0 Kg/m2 extremes included with minimum of 48 kg weight.
- •Subjects with normal findings as determined by baseline history, physical examination and vital sign examination.
- •Subjects with clinically acceptable findings as determined by haemogram, biochemistry (including ALT and AST), urinalysis, 12 lead ECG and chest X-ray (if done).
- •Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice, any alcoholic products, the use of cigarettes and the use of tobacco products for 48.00 hours prior to dosing until the last blood sample collection in each study period and adherence to all study restrictions.
- •No history of significant alcoholism.
- •No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs for the last 06 months.
- •Non-smokers as evident from the history obtained.
- •Willing to provide written informed consent to participate in the study.
排除标准
- •Known history of hypersensitivity to Vonoprazan or related drugs or any of the excipients.
- •Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days prior to dosing day.
- •Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of IP.
- •Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- •History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
- •Not eligible as per Online Volunteer Information System (OVIS).
- •Volunteer who have donated blood or experienced loss of blood of up to 150 ml within 30 days or 150 ml to 250 ml within 60 days or more than 250 ml within 90 days (exclude blood loss for screening) prior to first dose of study.
- •History of malignancy or other serious diseases.
- •Abnormal liver function test during the screening.
- •Subjects with positive result of HIV tests or HBsAg or Hepatitis-C tests during screening.
- •Found positive in breath alcohol test and/or urine test for drug abuse.
- •History of problems in swallowing of tablet/capsule.
- •Any contraindication to blood sampling.
- •Use of hormonal contraceptives either oral or implants.
研究者
Dr Nirav Panchal
Sycon Clinical Research Pvt Ltd.