CTRI/2012/10/003074尚未招募未知
A RANDOMISED, OPEN LABEL, BALANCED, SINGLE CENTRE, TWO PERIOD, TWOTREATMENT, TWO SEQUENCE, SINGLE DOSE, CROSSOVER, BIOEQUIVALENCE STUDY OFNISOLDIPINE 34 MG EXTENDED RELEASE TABLET TO SULAR® 34 MG EXTENDEDRELEASE TABLET
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1. Provision of signed and dated written informed consent prior to
- •any study specific procedures
- •2. Willing and able to comply with the study procedures, restrictions
- •and requirements
- •3. Adult males and females (of non-childbearing potential) aged 18 to 45 years (inclusive) at the time of signing informed consent
- •4. 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
- •5. Volunteer must be able to communicate effectively with the study
- •6. 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)
- •7. 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
- •8. Adequate organ function as determined by laboratory
- •assessments within the institutional normal range including the
- •following parameters: hematology, serum chemistry and serology)
- •9. Subjects who are negative for hepatitis B surface antigen
- •(HBsAg), hepatitis C antibody and human immunodeficiency virus
- •(HIV) I and II tests at screening
- •10. 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
- •? 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
- •11. 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
- •12. 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
- •1. Participation in any investigational study or received an
- •investigational drug within a period of 3 months prior to admission in
- •2. History of drug abuse, or alcohol dependence or abuse.
- •3. History of any allergies (asthma, urticaria) including drug allergies
- •4. Known hypersensitivity or allergy to Nisoldipine or any of the
- •excipients or related
- •5. 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)
- •6. 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 96.2°F or more than 99.8°F
- •7. Clinical laboratory test value outside the acceptable reference
- •range and when confirmed on re-examination and deemed to be
- •clinically significant
- •8. Subject who has donated blood in the 12 weeks prior to the
- •admission in Period I.
- •9. Clinically significant illness (any body system) during the 4 weeks
- •prior to admission in Period I (as determined by the investigators).
- •10. 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.
- •11. 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.
- •12. Positive result in breath analysis test for alcohol.
- •13. Positive urine drug screening results for any of the following:
- •cocaine, tetrahydrocannabinol, barbiturates, amphetamines,
- •benzodiazepines, and opioids.
- •14. Positive results in cotinine test.
- •15. History of difficulty in swallowing tablets/ capsules.
- •16. Positive test for pregnancy for female subjects or lactating
- •17. Inability to be venipunctured and/or tolerate venous puncture
研究者
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