ACTRN12616001475437已完成1 期
An Healthy Volunteer, Open-Label, Cross-Over Phase I Study to Determine the Safety, Tolerability and Pharmacokinetics of a Single Oral Dose of AWP-09VDB-S under Fed and Fasted Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
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 65 Years（—）
- 性别
- All
入选标准
- •1. Adult male and/or female healthy volunteers with a minimum age of at least 18 years and maximum age of 65 years at the time of screening.
- •2. Medically healthy with clinically insignificant screening results (e.g. laboratory profiles, medical history, ECGs, physical exam) as judged by the PI.
- •3. Negative urine drug screen /alcohol breath test prior to Day -1.
- •4. Availability of participant for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed, Informed Consent Form.
- •5. If male, agrees to be sexually abstinent or to use a condom (with the female sexual partner also to use an effective method of contraception) when engaging in sexual activity from admission through completion of the end-of study. Participants will be advised to use a condom (with the female sexual partner also to use an effective method of contraception) for 30 days following the last administration of the investigational product, and to not donate sperm during this same period of time.
- •6. Females of childbearing potential must either be sexually inactive (abstinent) for 14 days prior to the first administration of the investigational product and remain so through 30 days following the final dosing of the investigational product, or have been using one of the following acceptable methods of birth control for the times specified:
- •a. Intra-uterine device (IUD) in place for at least 3 months prior to the first administration of the investigational product.
- •b. Double barrier method (e.g., condom and diaphragm) for at least 14 days prior to the first administration of investigational product.
- •c. Male partner who is surgical sterile (vasectomy) at least 6 months prior to the first administration of investigational product and is the sole sexual partner for that female participant.
- •d. Adequate hormonal contraception.
- •Female participants who claim to be sexually inactive, but become sexually active during the course of the study must agree to use a double barrier method (e.g., condom and diaphragm) from the time of the start of sexual activity through 30 days following the final dosing.
- •In addition, female participants of childbearing potential will be advised to remain sexually inactive or to keep the same birth control method for at least 30 days following the final dosing of the investigational product.
- •7. Females of non-childbearing potential have undergone one of the following sterilization procedures at least 6 months prior to the first investigational product administration:
- •a. Sterilization (with a copy of the confirmation test) and be using a barrier method (condom or diaphragm) throughout the study;
- •b. bilateral tubal ligation with a barrier method (condom or diaphragm) throughout the study;
- •c. hysterectomy;
- •d. bilateral oophorectomy;
- •or be postmenopausal with amenorrhea for at least 1 year prior to the first administration of the investigational product and follicle stimulating hormone (FSH) serum levels. FSH serum levels less than or equal to 20 IU/L.
排除标准
- •1. History of confirmed chronic and/or serious pulmonary disease, including asthma or chronic obstructive pulmonary disease (COPD).
- •2. Known or suspected history of hypersensitivity to any components of the investigational product – zanamivir, glycerol or diglycerides.
- •3. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- •4. Presence or history of clinically significant lung infection
- •5.Presence or history of influenza within the past three weeks.
- •6. Participants who meet the following criteria at baseline:
- •a. ALT or AST greater than or equal to 3xULN and bilirubin greater than or equal to 2xULN, or
- •b. ALT greater than or equal to 5xULN.
- •7. Participating in a clinical trial with an investigational drug within 30 days preceding this trial.
- •8. Blood donation within 45 days preceding this trial.
- •9. Participants who are known to have serum hepatitis or who are carriers of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody or have a positive result to the test for Human Immunodeficiency Virus (HIV).
- •10. Use of zanamivir (Relenza Registered Trademark) within 4 days preceding confinement for either dose period.
- •Presence or history of clinically significant lung infection
研究者
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