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

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

To compare the pharmacokinetics and safety after a single dose administration of IN-G00002 and IN-R00002 in healthy adult volunteers

Study Overview

• Status: Active, not recruiting
• Conditions: Non-valvular Atrial Fibrillation (NVAF)
• Intervention / Treatment: Drug: IN-R00002; Drug: IN-G00002

Detailed Description

A randomized, open-label, single-dose, crossover study

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Siheung, Korea, Republic of
    • Central Hospital, Clinical Trial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A; R->T R: IN-R00002 T: IN-G00002	Drug: IN-R00002; Single administration of IN-R00002 60mg; Drug: IN-G00002; Single administration of IN-G00002 60mg
Experimental: Sequence B; T->R R: IN-R00002 T: IN-G00002	Drug: IN-R00002; Single administration of IN-R00002 60mg; Drug: IN-G00002; Single administration of IN-G00002 60mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameter	AUClast of Edoxaban	Up to Day 2
PK parameter	Cmax of Edoxaban	Up to Day 2

Collaborators and Investigators

• Sponsor: HK inno.N Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2024
• Primary Completion (Actual): October 8, 2024
• Study Completion (Estimated): January 14, 2025

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Estimated): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: IN_LXA_101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No