To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C716 and C716R in Healthy Adults

An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over to Evaluate the Safety and Pharmacokinetics of AJU-C716 Compared to C716R in Healthy Adult Volunteers

To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C716 and C716R in Healthy Adults

Study Overview

• Status: Active, not recruiting
• Conditions: Dyslipidemia; Hypercholesterolemia
• Intervention / Treatment: Drug: Test Drug; Drug: Reference Drug

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • H+ Yangji Hospital, Seoul, Republic of South Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy adults between 19 and 55 years of age at the time of screening.
2. Weight ≥ 50 kg for men or ≥ 45 kg for women, with a calculated body mass index(BMI) of 18 to 30 kg/m² at the time of screening.
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 the clinical trial based on laboratory test results(hematology, blood chemistry, serum, and urine tests) and 12-lead ECG findings during screening.
5. 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.
6. Those who agree to use highly effective methods of contraception(excluding hormonal methods) to prevent pregnancy, either for themselves or their spouse/partner, from the first administration of the investigational medicinal product until one week after the last administration, and who agree not to donate sperm or eggs during this period.

Exclusion Criteria:

1. 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.
2. Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug.
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, Beer 250mL or liquor: 30mL), Smoke: 20 cigarettes/day.

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
   • Individuals with severe hepatic impairment, biliary obstruction, or cholestasis
   • Those taking cyclosporin
   • Those with myopathy
   • Those with a history of hypersensitivity or allergy to Sunset Yellow FCF (Yellow No. 5, Sunset Yellow FCF).
   • 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A; Period 1: Reference Drug, Single dose/ Period 2: Test Drug, Single dose	Drug: Test Drug; AJU-C716; Drug: Reference Drug; C716R
Experimental: Sequence B; Period 1: Test Drug, Single dose/ Period 2: Reference Drug, Single dose	Drug: Test Drug; AJU-C716; Drug: Reference Drug; C716R

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUCt of AJU-C716	Pre-dose(0 hours) ~ 36 hours
Cmax of AJU-C716	Pre-dose(0 hours) ~ 36 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Ka of AJU-C716	Pre-dose(0 hours) ~ 36 hours
Percentage of concentration relative to Cmax of AJU-C716	Pre-dose(0 hours) ~ 36 hours
AUCinf of AJU-C716	Pre-dose(0 hours) ~ 36 hours
AUCt/AUCinf of AJU-C716	Pre-dose(0 hours) ~ 36 hours
t1/2 of AJU-C716	Pre-dose(0 hours) ~ 36 hours

Collaborators and Investigators

• Sponsor: AJU Pharm Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2026
• Primary Completion (Estimated): June 26, 2026
• Study Completion (Estimated): June 26, 2026

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hypercholesterolemia; Dyslipidemias; Investigative Techniques; Evaluation Studies as Topic; Drug Development; Drug Evaluation
• Other Study ID Numbers: 26PHL12001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No