Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Repeat Dose Zana… (NCT00989404) | Clinical Trial Compass
CompletedPhase 1
Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Repeat Dose Zanamivir/Placebo Via Devices Administered Twice Daily for 5 Days
United States18 participantsStarted 2009-10-12
Plain-language summary
The purpose of this study is to compare the safety and tolerability of Zanamivir using a Rotahaler device presentation to placebo within the Rotahaler presentation and to the Diskhaler device.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The subject is healthy as judged by a responsible physician with no clinically significant abnormality identified on a medical evaluation
* Male and female volunteers from 18-55 years of age, inclusively, at the time of signing the informed consent.
* A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea or Child-bearing potential and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point.
* Male subjects must agree to use one of the contraception methods listed in the protocol.
* Nonsmokers defined as abstinence from cigarette smoking for the previous 12 months before enrollment into the study.
* Body mass Index of 19-30 kg/m2.
* FEV1 greater than or equal to 85 percent of the predicted and FEV1/FVC ratio greater than or equal to 0.7 at screening.
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion Criteria:
* The subject has a positive pre-study urine drug/ alcohol screen.
* Significant pulmonary disease, such as chronic obstructive pulmonary disease, asthma, or other pulmonary diseases th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.