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

NCT06725355 | Active Not Recruiting Phase 1

• 1 other identifier: IN_LXA_101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-valvular Atrial Fibrillation (NVAF)

Outcome Measures

Primary Outcomes (2)

• PK parameter

  AUClast of Edoxaban

  Up to Day 2

• PK parameter

  Cmax of Edoxaban

  Up to Day 2

Study Arms (2)

Sequence A

EXPERIMENTAL

R-\>T R: IN-R00002 T: IN-G00002

Drug: IN-R00002; Drug: IN-G00002

Sequence B

EXPERIMENTAL

T-\>R R: IN-R00002 T: IN-G00002

Drug: IN-R00002; Drug: IN-G00002

Interventions

IN-R00002 DRUG

Single administration of IN-R00002 60mg

Sequence A; Sequence B

IN-G00002 DRUG

Single administration of IN-G00002 60mg

Sequence A; Sequence B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Central Hospital, Clinical Trial Center

Siheung, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 10, 2024
• Study Start: August 16, 2024
• Primary Completion: October 8, 2024
• Study Completion: January 14, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-11

Locations

KR (1)