Clinical Trials in South Korea / NCT06725355
Active, not recruiting
Phase 1
To Compare the Pharmacokinetics and Safety After a Single Dose Administration of IN-G00002 and IN-R00002 in Healthy Adult Volunteers
NCT06725355 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Non-valvular Atrial Fibrillation (NVAF)
Investigational drug(s) / intervention(s)
IN-R00002IN-G00002
IN-R00002: Single administration of IN-R00002 60mg
IN-G00002: Single administration of IN-G00002 60mg
Study summary
To compare the pharmacokinetics and safety after a single dose administration of IN-G00002 and IN-R00002 in healthy adult volunteers
Eligibility
Inclusion Criteria:
* Healthy adult volunteers aged ≥ 19 years at screening
* Body weight \> 60kg and Body mass index (BMI) in the range of 18.0 and 30.0 kg/㎡
* Subjects who do not have congenital or chronic diseases requiring treatment and have no pathological symptoms or findings as a result of physical examination
* Determined by the investigator to be eligible for study participation based on the results of screening tests (clinical laboratory tests, vital signs, physical examination, 12-lead ECG) conducted according to the IP characteristics
* Subjects who decided to participate in the study and signed informed consent form voluntarily after receiving detailed explanation of the study and fully understanding
Exclusion Criteria:
* Subjects who have taken the drug which can induce or inhibit drug metabolism enzyme within 4 weeks prior to the 1st IP administration
* Subjects who have participated in any other clinical study or bioequivalnece study within 6 months prior to the 1st IP administration
* Subjects who have donated whole blood within 8 weeks prior to the 1st IP administration or have donated blood components or received transfusion within 2 weeks prior to the 1st IP administration
* Pregnant(positive urine HCG) or breastfeeding women if female
* Subject who have continued drink of alcohol within 1 month prior to the 1st IP administration (female: \> 14 glasses per week, male \> 21 glasses per week)
* Subjects with a presence and a history of surgery or gastrointestinal diseases which might significantly change absorption of medicines
* Pregnant(positive urine HCG) or breastfeeding women if female
* Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* Subjects or spouses (or partners) are unable to use an effective method of contraception (e.g., correctly placed intrauterine device, sterilization surgery (vasectomy, tubal ligation, etc.), barrier method (spermicide and condom, a concomitant use of contraceptive diaphragm, vaginal sponge or cervical cap)), throughout the study
* Subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion/exclusion criteria.
Primary outcome measure(s)
- PK parameter — Up to Day 2
AUClast of Edoxaban - PK parameter — Up to Day 2
Cmax of Edoxaban
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Central Hospital, Clinical Trial Center | Siheung | South Korea |
More HK inno.N Corporation trials in South Korea
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06725355 on ClinicalTrials.gov ↗ ← All trials in South Korea