Clinical trial NCT06931327: To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C711 in Healthy Adults
Official title: An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate Bioequivalence of AJU-C711 Compared to C711R in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia
Lead sponsor: AJU Pharm Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-17
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and pharmacokinetic characteristics of AJU-C711 in healthy adults


Eligibility criteria: Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19-year-old
2. Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
3. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests

6. Those who agree to contraception during the participation of clinical trial 7. 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

Exclusion Criteria:

1. Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
2. 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
3. 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
4. Those who has a history of gastrointestinal disease or surgery which may affect the absorption of the drug
5. Those who exceeding an alcohol consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, liquor: 30mL or Beer 250mL)
6. 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 severe hepatic impairment or biliary atresia and cholestasis
   * Those taking cyclosporin
   * Those with myopathy
   * Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, dihydropyridine sensitivity, angioedema
   * Those who has Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
7. Those who has a history of mental illness
8. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons
9. Women who are pregnant or who may be pregnant and breastfeed

Primary outcomes:
measure: AUCt of AJU-C711
timeFrame: Pre-dose (0 hr) 10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 hr
measure: Cmax of AJU-C711
timeFrame: Pre-dose (0 hr) 10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Bumin Hospital, Seoul, Republic of South Korea
Study officials:
References: