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

HK inno.N

Status and phase: Active, not recruiting; Phase 1

Conditions: Non-valvular Atrial Fibrillation (NVAF)

Treatments: Drug: IN-G00002; Drug: IN-R00002

Study type: Interventional

Funder types: Industry

Identifiers

NCT06725355

IN_LXA_101

Details and patient eligibility

About

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

Full description

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

Enrollment: 60 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Sequence A

Experimental group

Description:

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

Treatment:

Drug: IN-R00002

Drug: IN-G00002

Sequence B

Experimental group

Description:

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

Treatment:

Drug: IN-R00002

Drug: IN-G00002