To Compare the Pharmacokinetics and Safety After a Single Dose Administration of IN-G00002 and IN-R00002 in Healthy Adult Volunteers

Phase 1

Active, not recruiting

• Conditions: Non-valvular Atrial Fibrillation (NVAF)
• Interventions: Drug: IN-R00002; Drug: IN-G00002

• Registration Number: NCT06725355
• Lead Sponsor: HK inno.N Corporation

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

Study Timeline

• Study Start: 2024-08-16
• Primary Completion: 2024-10-08
• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Study Completion: 2025-01-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence B	IN-R00002	T-\>R R: IN-R00002 T: IN-G00002
Sequence B	IN-G00002	T-\>R R: IN-R00002 T: IN-G00002
Sequence A	IN-R00002	R-\>T R: IN-R00002 T: IN-G00002
Sequence A	IN-G00002	R-\>T R: IN-R00002 T: IN-G00002

Primary Outcome Measures

Name	Time	Method
PK parameter	Up to Day 2	Cmax of Edoxaban

Trial Locations

Locations (1)

Central Hospital, Clinical Trial Center; 🇰🇷 Siheung, Korea, Republic of