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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
Phase
Phase 1
Started
2024-08-16
Last updated
2024-12-10

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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
Accepted
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)

FacilityCityRegionStatus
Central Hospital, Clinical Trial Center Siheung 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