H plus Yangji Hospital
Seoul, Gwanak-gu, 08779, South Korea
Location contact
Eun Jung Lee Project Manager
CONTACT
Hee Ju Hong
PRINCIPAL_INVESTIGATOR
Not Yet Recruiting
NCT Number: NCT07297693
A Study to Evaluate the Pharmacokinetics and Safety Between HIP2503 and HCP1306 in Healthy Volunteers
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HIP2503 and HCP1306 in healthy volunteers.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
19 year–64 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age 19~64 years in healthy volunteers
- 18 kg/m^2 ≤ BMI ≤ 30 kg/m^2, weight(men) ≥55kg / weight(women) ≥45kg
- Agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 14 days after the administration of the last investigational drug
- Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial
Exclusion criteria
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
- Subjects who judged ineligible by the investigator
Treatment and study plan
HIP2503
DrugTake 1 orally disintegrating tablet once per period
HCP1306
DrugTake 1 tablet once per period
Primary outcomes
-
AUCt
Time frame: 0~72 hours
Pharmacokinetic evaluation
-
Cmax
Time frame: 0~72 hours
Pharmacokinetic evaluation
Secondary outcomes
-
Ka
Time frame: 0~72 hours
Pharmacokinetic evaluation
-
Concentration/Cmax_%
Time frame: 0~72 hours
Pharmacokinetic evaluation
-
AUCinf
Time frame: 0~72 hours
Pharmacokinetic evaluation
-
AUCt/AUCinf
Time frame: 0~72 hours
Pharmacokinetic evaluation
-
Tmax
Time frame: 0~72 hours
Pharmacokinetic evaluation
-
t1/2
Time frame: 0~72 hours
Pharmacokinetic evaluation
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Hanmi Pharmaceutical Company Limited
Industry
Registry information
Official study title
An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2-period, Crossover Study to Evaluate the Pharmacokinetics and Safety Between HIP2503 and HCP1306 in Healthy Subjects
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Dec 22, 2025
- Registry last updated
- Dec 22, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Not Yet Recruiting
A Study of HW243040 in Healthy Participants
NCT07737496
Healthy
Changsha, Hunan, China
View Trial Details
Not Yet Recruiting
A Study in Healthy People to Compare Two Tablet Formulations of Pramipexole
NCT07727785
Healthy
Biberach, Germany
View Trial Details
Not Yet Recruiting
A Study to Learn How the Study Medicine Called PF-08653945 is Taken up Into the Blood in Adults With Overweight or Obesity
NCT07725809
Body Weight, Healthy
Brussels, Bruxelles-capitale, Région de, Belgium
View Trial Details
Not Yet Recruiting
Pomegranate Dietary Supplements in AUD and ALD
NCT07678567
Alcohol Use Disorder, Alcohol-Induced Disorders
Louisville, Kentucky, United States
View Trial Details