A Study to Characterize the Pharmacokinetics/Pharmacodynamics and Effect of Food of DA-1229 in He… (NCT00961025) | Clinical Trial Compass
UnknownPhase 1
A Study to Characterize the Pharmacokinetics/Pharmacodynamics and Effect of Food of DA-1229 in Healthy Male Subjects
South Korea110 participantsStarted 2009-05
Plain-language summary
This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose-escalation study. The study is designed to describe the relationship between multiple doses and pharmacokinetic/pharmacodynamic parameters of DA-1229 as well as safety profile.
Who can participate
Age range
20 Years – 45 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:
* 20-45 years healthy male subjects
* Body weight :50-90kg, BMI between 18.5-25
* Blood glucose level of 70-110mg/dL on the FPG test
Exclusion Criteria:
* have a family history of diabetes
* Serum AST(SGOT), ALT(SGPT)\>1.25 times upper limit of normal
* Creatinine clearance rate\<80mL/min
* show SBP =\<100mmHg or \>=150mmHg, or DBP=\<65mmHg or \>=95mmHg, or tachycardia (PR\>=100times/min)
* have a history of drug abuse or show positive for drug abuse or cotinine at urine screening
* smokers
* can not digest high-fat or high-calorie food(applicable only for the 10mg dose group subjects
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
To characterize the pharmacokinetic/pharmacodynamic of DA-1229 in healthy male subjects
Timeframe: Multiple blood and urine samples will be collected for 120 hours after dosing of DA-1229