NCT06725355Active, not recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 10 Dec 2024
Brief summary (registry, in English)
To compare the pharmacokinetics and safety after a single dose administration of IN-G00002 and IN-R00002 in healthy adult volunteers
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 25 Nov 2024
- Start date
- 16 Aug 2024
- Primary completion date
- 8 Oct 2024
- Lead sponsor
- HK inno.N Corporation
- Diseases
- Atrial fibrillation
- NCT number
- NCT06725355
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 60
- From 16 Aug 2024 to the primary completion date, 8 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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 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
Other illness
- Subjects with a presence and a history of surgery or gastrointestinal diseases which might significantly change absorption of medicines
Lab values
- Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Other
- Pregnant(positive urine HCG) or breastfeeding women if female
- Pregnant(positive urine HCG) or breastfeeding women if female
- Subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion/exclusion criteria.
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Central Hospital, Clinical Trial Center Coordinator of this site? Confirm its status | Siheung | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.