A Bioequivalence Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of IN-R00002 and IN-G00002 in Healthy Adult Volunteers
| Registry | NCT06725355 |
|---|---|
| Status | Active not recruiting |
| Phase | Phase 1 |
| Study type | Interventional; randomized, crossover, masking: none, treatment |
| Enrollment | 60 (Estimated) |
| Sponsor | HK inno.N Corporation (Industry) |
| Conditions | Non-valvular Atrial Fibrillation (NVAF) |
| Interventions | IN-R00002, IN-G00002 (Drug) |
| Dates | start 2024-08-16, primary completion 2024-10-08, completion 2025-01-14 (estimated), first posted 2024-12-10, last updated 2024-12-10 |
| Locations | 1 site in South Korea |
Related Papers Related Patents Related Grants Related Experts
All trials for Non-valvular Atrial Fibrillation (NVAF) All trials of IN-R00002 All trials of IN-G00002
To compare the pharmacokinetics and safety after a single dose administration of IN-G00002 and IN-R00002 in healthy adult volunteers
A randomized, open-label, single-dose, crossover study
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Sequence A | Experimental | Drug: IN-R00002; Drug: IN-G00002 | R->T R: IN-R00002 T: IN-G00002 |
| Sequence B | Experimental | Drug: IN-R00002; Drug: IN-G00002 | T->R R: IN-R00002 T: IN-G00002 |
Sex: All, ages: 19 Years to any, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Central Hospital, Clinical Trial Center | Siheung | South Korea |