To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C711 in Healthy Adults

Phase 1

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: Test Drug; Drug: Reference Drug

• Registration Number: NCT06931327
• Lead Sponsor: AJU Pharm Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-29
• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-09
• Primary Completion: 2025-04-16
• Study First Posted: 2025-04-17
• Study Completion: 2025-04-18
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

5. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	Test Drug	Period 1: Reference Drug, single dose Period 2: Test Drug, single dose
Sequence B	Test Drug	Period 1: Test Drug, single dose Period 2: Reference Drug, single dose
Sequence A	Reference Drug	Period 1: Reference Drug, single dose Period 2: Test Drug, single dose
Sequence B	Reference Drug	Period 1: Test Drug, single dose Period 2: Reference Drug, single dose

Primary Outcome Measures

Name	Time	Method
AUCt of AJU-C711	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
Cmax of AJU-C711	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

Trial Locations

Locations (1)

Bumin Hospital, Seoul, Republic of South Korea; 🇰🇷 Seoul, Korea, Republic of