Biopharmaceutical Study of Glyco pMDI With or Without Charcoal Block vs IV Bolus in Healthy Volun… (NCT01176851) | Clinical Trial Compass
CompletedPhase 1
Biopharmaceutical Study of Glyco pMDI With or Without Charcoal Block vs IV Bolus in Healthy Volunteers
United Kingdom20 participantsStarted 2010-07
Plain-language summary
The purpose of this study is to investigate the pharmacokinetics, the absolute bioavailability and the lung bioavailability of inhaled Glyco pMDI.
Who can participate
Age range
18 Years – 65 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
. Males and females healthy volunteers aged 18-65 years;
. Written informed consent obtained before the first trial related activity.
. Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly.
. Body Mass Index (BMI) between 18.0 and 32.0 kg/m2;
. Non- or ex-smokers who smoked \< 5 pack years;
. Good physical and mental status;
. Normal blood pressure and heart rate;
. Electrocardiogram (ECG)considered as normal;
Exclusion criteria
. Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before inhalation of the study medication;
. Pregnant or lactating women or women of childbearing potential, UNLESS they are using one or more of the acceptable methods of contraception. Male subjects not willing to use an acceptable method of contraception.
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.
What they're measuring
1
Plasma and urine pharmacokinetics of glycopyrrolate
. Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C;
. Unsuitable veins for repeated venipuncture;
. History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen at screening;
. Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;
. Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol;