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

NCT ID: NCT06725355

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-16

Study Completion Date

2025-01-14

Brief Summary

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

Detailed Description

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

Conditions

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Non-valvular Atrial Fibrillation (NVAF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence A

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

Group Type EXPERIMENTAL

IN-R00002

Intervention Type DRUG

Single administration of IN-R00002 60mg

IN-G00002

Intervention Type DRUG

Single administration of IN-G00002 60mg

Sequence B

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

Group Type EXPERIMENTAL

IN-R00002

Intervention Type DRUG

Single administration of IN-R00002 60mg

IN-G00002

Intervention Type DRUG

Single administration of IN-G00002 60mg

Interventions

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IN-R00002

Single administration of IN-R00002 60mg

Intervention Type DRUG

IN-G00002

Single administration of IN-G00002 60mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HK inno.N Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Central Hospital, Clinical Trial Center

Siheung, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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IN_LXA_101

Identifier Type: -

Identifier Source: org_study_id