Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of HL1113-R1 and HL1113… (NCT07598968) | Clinical Trial Compass
CompletedPhase 1
Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of HL1113-R1 and HL1113-R2 in Healthy Adult Volunteers
South Korea35 participantsStarted 2023-06-18
Plain-language summary
This clinical trial is a two-arm, open-label, single-sequence, multiple oral dosings, cross-over design clinical trial to evaluate the safety and pharmacokinetic characteristics of HL1113-R1 and HL1113-R2 in healthy adult volunteers
Who can participate
Age range
19 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:
* Healthy adult subjects aged ≥19 years at the time of screening
* Subjects with no clinically significant congenital or chronic diseases based on screening, and no clinically significant findings on internal medicine examination (including, if necessary, electroencephalogram \[EEG\], electrocardiogram \[ECG\], chest examination, upper gastrointestinal endoscopy, or gastrointestinal radiography)
* etc.
Exclusion Criteria:
* Subjects who have received medications known to markedly induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 30 days prior to the screening visit
* Subjects who have received any medications that may affect the outcome of the study within 10 days prior to the screening visit
* etc.
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.
1This trial studied HL1113-R1 and HL1113-R2 in healthy volunteers — since I have hypertension or type 2 diabetes, not a healthy volunteer, how relevant are these Phase 1 safety and pharmacokinetic results to someone with my condition?
2Since this was a Phase 1 trial focused on measuring drug exposure in the body (AUCτ,ss) rather than on treating disease, what does that tell us about how early in development these drugs are, and does that affect whether I should consider any follow-up trials?
3The recruitment for this trial is already completed — are there any results or findings available yet that you think are worth knowing about, and are there any follow-on Phase 2 trials being planned that I might be a candidate for?
4Given that this trial only tested these compounds in healthy adults, do we know yet whether HL1113-R1 or HL1113-R2 is intended to replace or add to medications I'm already taking for hypertension or type 2 diabetes?
5Would it make more sense for me to continue or optimize my current standard treatment plan while keeping an eye on whether later-stage trials for these drugs become available?
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
AUCτ,ss
Timeframe: a steady state after 5~7 days of repeated administration