Non-valvular Atrial Fibrillation (NVAF)
Conditions
Brief summary
To compare the pharmacokinetics and safety after a single dose administration of IN-G00002 and IN-R00002 in healthy adult volunteers
Detailed description
A randomized, open-label, single-dose, crossover study
Interventions
DRUGIN-R00002
Single administration of IN-R00002 60mg
DRUGIN-G00002
Single administration of IN-G00002 60mg
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK parameter | Up to Day 2 | AUClast of Edoxaban |
Countries
South Korea
Outcome results
None listed