PK/PD Clinical Trial of YYD601 in Healthy Adult Male (NCT03558477) | Clinical Trial Compass
CompletedPhase 1
PK/PD Clinical Trial of YYD601 in Healthy Adult Male
South Korea30 participantsStarted 2017-09-19
Plain-language summary
A dose block-randomized, open-label, parallel clinical trial
Who can participate
Age range
19 Years
Sex
MALE
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:
* Healthy adult male above 19 years old when getting a screening test.
* Subjects who have over 50kg weight, included in the IBW± 20% range. \[IBW(kg)={height(cm)-100}x0.9
* Subjects who haven't any congenital or chronic disease, and any other disease following the medical examination.
* Subjects who are confirmed as a participant by the serum test, hematologital test, blood chemistry tests, urine tests, and clinical laboratory test, 12-lead EKG etc following the characteristics aboht the IP within the 3 weeks before investogator products are administrated.
* Subjects who voluntarily decide to participated in this trial after comletely understand about this clinical trial.
Exclusion criteria
* Subjects who are judged not suitable to participated in this trial.
* Other specific exlusion criteria is identified in the protocol.
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
half-life
Timeframe: Evaluate the before/after treatment period(5 days per phase)
2
Tmax
Timeframe: Evaluate the before/after treatment period(5 days per phase)
3
Concentration
Timeframe: Evaluate the before/after treatment period(5 days per phase)
4
AUC
Timeframe: Evaluate the before/after treatment period(5 days per phase)