Status:
ACTIVE_NOT_RECRUITING
To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C714 and C714R in Healthy Adults
Lead Sponsor:
AJU Pharm Co., Ltd.
Conditions:
Dyslipidemia
Eligibility:
All Genders
19-65 years
Phase:
PHASE1
Brief Summary
To evaluate the safety and pharmacokinetic characteristics of AJU-C714 and C714R in healthy adults
Eligibility Criteria
Inclusion
- Healthy adult over 19 years of age and under 65 years of age.
- Weight ≥ 50 kg (man) or 45 kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2.
- Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings.
- Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests.
- Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial.
- Those who agree to contraception during the participation of clinical trial.
Exclusion
- Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month or the first administration of clinical trial drug within 10 days.
- Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug.
- Those who donated whole blood within 8 weeks, received apheresis within 2 weeks, blood transfusion within 1 month or can't refrain from donating blood from the time of written consent until the end of the study.
- Those who has a history of gastrointestinal disease or surgery which may affect the absorption of the drug.
- Those who exceeding an alcohol consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL or liquor: 30mL), Smoke: 20 cigarettes/day.
- Those who has under
- Those who are hypersensitive to component of the Investigational product and have the medical history
- Those with active liver disease or persistent elevation of aminotransferase levels of unknown
- Those with myopathy
- Those taking cyclosporin
- Those with renal impairment with severe renal failure
- Those with Hypothyroidism
- Those who has Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- Those who has a history of mental illness.
- Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons.
- Women who are pregnant or who may be pregnant and breastfeed.
Key Trial Info
Start Date :
May 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06933459
Start Date
May 24 2025
End Date
June 24 2025
Last Update
June 12 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
H+ Yangji Hospital, Seoul, Republic of South Korea
Seoul, South Korea