ACTRN12611000106932已完成不适用
Pharmacokinetics and Bioavailability of a New SublingualFentanyl Wafer (Waferyl (TM)) in Healthy Volunteers.
iX Biopharma Pte Ltd0 个研究点目标入组 24 人开始时间: 2011年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •1.Male or female aged between 18 and 45 years (inclusive).
- •2.Healthy volunteers – healthy volunteers are defined as individuals who are free from clinically significant illness or disease as determined by their medical/surgical history, physical examination (including height and weight), 12-lead ECG and clinical laboratory determinations.
- •3.Normotensive (systolic blood pressure (BP) between 90 mmHg and 140 mmHg, and diastolic BP between 60 mmHg and 90 mmHg).
- •4.Body Mass Index (BMI; calculated as weight [kg] / height [m2]) between 18 and 30 kg/m2.
- •5.HIV, Hepatitis B and Hepatitis C negative.
- •6.Adequate venous access in the left and right arm to allow collection of a number of blood samples.
- •7.Able to read and communicate in English with the Investigator and his/her staff.
- •8.Provide written informed consent to participate in the study and be willing to comply with the study procedures.
- •9. No abnormal finding of clinical relevance at the Screening evaluation.
排除标准
- •1.Received or is anticipated to receive a new prescription systemic or topical medication within 14 days prior to the start of dosing or an over–the-counter medicine 48 hours prior to the start of dosing, with the exception of the contraceptive pill for female volunteers.
- •2.Known allergy or hypersensitivity reactions to naltrexone or fentanyl or other opioid analgesics (codeine, oxycodone, hydrocodone, morphine etc.),
- •3.History or evidence of drug abuse and/or positive urine drug test prior to start of the study.
- •4.Any condition that would interfere with drug absorption.
- •5.Abnormal laboratory test results deemed clinically significant by the Medical Officer (Principal Investigator or medically qualified nominee) within 28 days before enrolment.
- •6.As a result of medical review, physical examination (including height and weight) or Screening investigations, the Medical Officer considers the volunteer unfit for the study.
- •7.Positive alcohol breath test, which remains positive following one repeat.
- •8. Evidence of clinically relevant oral, cardiovascular, hematological, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, or skin disorder, or history of hypertension or heart disease.
- •9.Acute therapy for a serious infection within 30 days of study entry.
- •10.Currently suffers from clinically significant systemic allergic disease or has a history of significant drug allergies including a history of: anaphylactic reaction; allergic reaction due to any drug which leads to significant morbidity (e.g. penicillin); neuro malignant syndrome or malignant hyperthermia.
- •11.Have participated in a clinical trial or have received an experimental therapy within 30 days or 10 half-lives of the drug, whichever is the longer, prior to dosing.
- •12.Blood donation of greater than 400 mL within 8 weeks before the first dose administration.
- •13.Males who regularly drink more than four (4) units of alcohol daily (1 unit = 300 mL beer, 1 glass wine, 1 measure spirit) or those who may have difficulty abstaining from alcohol during the 48 hours prior to dose administration and until completion of blood sampling.
- •14.Females who regularly drink more than two (2) units of alcohol daily (1 unit = 300 mL beer, 1 glass wine, 1 measure spirit) or those who may have difficulty abstaining from alcohol during the 48 hours prior to dose administration and until completion of blood sampling.
- •15.Positive serum pregnancy test at screening or a positive urine pregnancy test at check-in for female participants.
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