To Compare the Pharmacokinetics and Safety After a Single Dose Administration of IN-G00002 and IN… (NCT06725355) | Clinical Trial Compass
Active — Not RecruitingPhase 1
To Compare the Pharmacokinetics and Safety After a Single Dose Administration of IN-G00002 and IN-R00002 in Healthy Adult Volunteers
South Korea60 participantsStarted 2024-08-16
Plain-language summary
To compare the pharmacokinetics and safety after a single dose administration of IN-G00002 and IN-R00002 in healthy adult volunteers
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 gastroin…