A RANDOMISED, OPEN LABEL, BALANCED, SINGLE CENTRE, TWO PERIOD, TWOTREATMENT, TWO SEQUENCE, SINGLE DOSE, CROSSOVER, BIOEQUIVALENCE STUDY OFNISOLDIPINE 34 MG EXTENDED RELEASE TABLET TO SULARÂ® 34 MG EXTENDEDRELEASE TABLET

InnoPharma Inc1 个研究点分布在 1 个国家目标入组 48 人开始时间: 2012年12月28日最近更新: 2012年10月26日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: InnoPharma Inc
入组人数: 48
试验地点: 1
主要终点: To assess the oral bioequivalence of Nisoldipine

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To assess the oral bioequivalence of Nisoldipine 34 mg extended release tablet manufactured by InnoPharma Inc. and Sular

Â® (Nisoldipine) 34 mg extended release tablet manufactured for Shionogi Pharma, Inc., manufactured by SkyePharma production SAS in healthy human adult subjects, under fasting conditions Bioequivalence of the test formulation with that of the reference formulation under fasting condition will be concluded if the 90% confidence intervals for the geometric mean ratios for C

max, AUC(0-inf) and AUC(0-last) for Nisoldipine fall entirely within the acceptance range of 80.00 to 125.00%.

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

•Provision of signed and dated written informed consent prior to any study specific procedures
•Willing and able to comply with the study procedures, restrictions and requirements
•Adult males and females (of non-childbearing potential) aged 18 to 45 years (inclusive) at the time of signing informed consent
•Body mass index (BMI) 19.0 to 25.0 kg/m2 (inclusive) and a body weight of more than 50 kg for males and 45 kg for females
•Volunteer must be able to communicate effectively with the study personnel.
•Volunteer must be non-smoker and non consumer (user) of any tobacco containing product (not consumed any form of tobacco in the past 6 months)
•In general good health as determined by an experienced physician based on a comprehensive medical history and physical examination.
•Minor abnormalities in laboratory testing are allowable if not contraindicated by this protocol, and if in the estimation of the Investigator, pose no additional risk to participation nor interference with study procedures
•Adequate organ function as determined by laboratory assessments within the institutional normal range including the following parameters: hematology, serum chemistry and serology)
•Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening
•Females must have a negative pregnancy test at screening and on admission to the study centre, must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria: ?
•Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation ?
•Postmenopausal; Have attained menopause at least 1 year back
•In case if childbearing, must be using a medically acceptable form of birth control (such as foam, jellies, diaphragm, intra-uterine device (IUD) or abstinence for the duration of the study as judged by the Investigator
•Male subjects should be willing to use a condom (with spermicide) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the first administration of the investigational medicinal product until 3 months after administration of the investigational medicinal product.

排除标准

•Participation in any investigational study or received an investigational drug within a period of 3 months prior to admission in period I.
•History of drug abuse, or alcohol dependence or abuse.
•History of any allergies (asthma, urticaria) including drug allergies
•Known hypersensitivity or allergy to Nisoldipine or any of the excipients or related drugs
•Presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, hepatic, immunologic, haematological, endocrine, or nervous system (s) or psychiatric disease or other condition that may interfere with the absorption, distribution, metabolism or excretion of the investigational medicinal product, or would place the subject at increased risk, as determined by the investigator(s)
•Volunteer whose: ?
•Systolic blood pressure less than 90 mmHg or more than 140 mmHg, diastolic blood pressure less than 60 mmHg or more than 90 mmHg after 5 minutes rest at screening or predose in Period I ?
•Sitting pulse rate below 55 beats per minute or above 100 beats per minute after 5 minutes rest ?
•Respiratory rate below 10 or above 20 beats per minute ?
•Oral temperature less than 96.2Â°F or more than 99.8Â°F
•Clinical laboratory test value outside the acceptable reference range and when confirmed on re-examination and deemed to be clinically significant
•Subject who has donated blood in the 12 weeks prior to the admission in Period I.
•Clinically significant illness (any body system) during the 4 weeks prior to admission in Period I (as determined by the investigators).
•Subject who has consumed grapefruit, grapefruit juice or/and grapefruit containing products, Seville oranges or quinine (tonic water) within 96 hours prior to admission in Period I.
•Use of any prescription drug(s) in the 14 days prior to admission in Period I or over-the-counter medication or herbal medications 14 days prior to admission in Period I.
•Positive result in breath analysis test for alcohol.
•Positive urine drug screening results for any of the following: cocaine, tetrahydrocannabinol, barbiturates, amphetamines, benzodiazepines, and opioids.
•Positive results in cotinine test.
•Positive test for pregnancy for female subjects or lactating females
•Inability to be venipunctured and/or tolerate venous puncture.